Trial Outcomes & Findings for Pancreatic Endotherapy for Refractory Chronic Pancreatitis (NCT NCT04232670)
NCT ID: NCT04232670
Last Updated: 2025-09-24
Results Overview
The percent change in average daily pain score from the daily diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. The investigators employed the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Day -14 to Day 90
Results posted on
2025-09-24
Participant Flow
Participant milestones
| Measure |
EUS + SHAM
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + SHAM: Endoscopic Ultrasound
|
EUS + Pancreatic Endotherapy
If randomized to endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
EUS + Pancreatic Endotherapy: Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pancreatic Endotherapy for Refractory Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
EUS + SHAM
n=6 Participants
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + SHAM: Endoscopic Ultrasound
|
EUS + Pancreatic Endotherapy
n=8 Participants
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
EUS + Pancreatic Endotherapy: Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
46.5 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -14 to Day 90Population: The analysis population is the 9 participants who completed the Ecological Momentary Assessment (EMA) at both the start of the study and at the 90-day follow-up.
The percent change in average daily pain score from the daily diaries during the 14-day period preceding the 90-day assessment, compared to the average daily pain reported during the 14-day run-in. The investigators employed the standardized 11-point Numeric Rating Scale (NRS) to capture average daily pain with the empirically-supported anchors of 0=No Pain and 10=Worst Pain Imaginable.
Outcome measures
| Measure |
EUS + SHAM
n=4 Participants
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + SHAM: Endoscopic Ultrasound
|
EUS + Pancreatic Endotherapy
n=5 Participants
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
EUS + Pancreatic Endotherapy: Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
|
|---|---|---|
|
Percent Change in Average Daily Pain Score on the Numeric Rating Scale
|
-36.6 Percent Change
Interval -39.3 to -11.6
|
-53.7 Percent Change
Interval -100.0 to -27.9
|
Adverse Events
EUS + SHAM
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
EUS + Pancreatic Endotherapy
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EUS + SHAM
n=6 participants at risk
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + SHAM: Endoscopic Ultrasound
|
EUS + Pancreatic Endotherapy
n=8 participants at risk
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
EUS + Pancreatic Endotherapy: Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
|
|---|---|---|
|
Hepatobiliary disorders
Acute pancreatitis > 30 days from randomization
|
33.3%
2/6 • Number of events 8 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
25.0%
2/8 • Number of events 2 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Hepatobiliary disorders
Acute pancreatitis within 30 days of randomization
|
16.7%
1/6 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
25.0%
2/8 • Number of events 2 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
4/6 • Number of events 6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
50.0%
4/8 • Number of events 14 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Hepatobiliary disorders
Chronic pancreatitis
|
50.0%
3/6 • Number of events 4 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
25.0%
2/8 • Number of events 3 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
General disorders
Acute pain
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Gastrointestinal disorders
Post procedural pain
|
16.7%
1/6 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 2 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Psychiatric disorders
Active Suicidal Ideation
|
16.7%
1/6 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
0.00%
0/8 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Respiratory, thoracic and mediastinal disorders
Anaphylaxis
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Infections and infestations
Coronavirus infection
|
16.7%
1/6 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
0.00%
0/8 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Hepatobiliary disorders
Elevated liver enzyme levels
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Gastrointestinal disorders
Suprapubic pain
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
General disorders
Temporal headache
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
12.5%
1/8 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
0.00%
0/8 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
Other adverse events
| Measure |
EUS + SHAM
n=6 participants at risk
All subjects will undergo anesthesia administered sedation and endoscopic ultrasound (EUS). The endoscopist will assess the pancreas for parenchymal and ductal features of chronic pancreatitis and confirm the absence of exclusion criteria (such as the presence of an occult pancreatobiliary malignancy).
EUS + SHAM: Endoscopic Ultrasound
|
EUS + Pancreatic Endotherapy
n=8 participants at risk
If randomized to ERCP with pancreatic endotherapy, the endoscopist will proceed with this intervention immediately following the completion of EUS and treatment allocation (during the same anesthesia). Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement. Overall technical success will be defined by the ability to insert at least one pancreatic stent across the dominant main pancreatic duct obstruction. Technical success for pancreatic stone treatment will be defined by the ability to remove all fluoroscopically visible main pancreatic duct stones.
EUS + Pancreatic Endotherapy: Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
25.0%
2/8 • Number of events 2 • An Adverse Event form was used to document reportable adverse events (AEs) for this study, which included: 1. All non-serious adverse events related to abdominal pain in addition to all serious adverse events were reported through Day 30 2. All serious adverse events (SAEs) were reported through the end of study (12 months post randomization) 3. All acute pancreatitis events or pancreatitis-related pain events that occur were reported through end of study ((12 months post randomization).
Unblinded personnel reported AEs between randomization and Day 30. Blinded personnel reported AEs between Day 30 post randomization \& up to the 90 day visit, then unblinded personnel reported any SAEs at Day 90 and afterwards.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place