Trial Outcomes & Findings for Study of Forceps Cannulation During ERCP (NCT NCT05336630)
NCT ID: NCT05336630
Last Updated: 2025-10-30
Results Overview
A difficult cannulation will be defined as any cannulation that results in any of the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or more unintentional pancreatic wire passages.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
Baseline (during the ERCP)
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Forceps-assisted Group
Those who underwent cannulation with forceps-assisted technique
n=70
Age, years (SD) 61.9 (16.3)
Gender Male, n (%) 33 (47.1) Female, n (%) 37 (52.9)
BMI, kg/m2 29.3
ERCP indication Choledocholithiasis, n (%) 29 (41.4) Extrahepatic malignant biliary obstruction, n (%) 20 (28.6) Intrahepatic malignant biliary obstruction, n (%) 4 (5.7) Chronic pancreatitis 2 (2.9) Sphincter of oddi dysfunction, n (%) 0 (0) Pancreatic stone disease, n (%) 0 (0) Bile leak, n (%) 5 (7.1) Pancreatic fistula, n (%) 1 (1.4) Dorsal duct intervention, n (%) 1 (1.4) Other, n (%) 8 (11.4)
Trainee involvement, n (%) 43 (61.4)
Papilla classification type I, n (%) 45 (64.3) II, n (%) 6 (8.6) III, n (%) 14 (20.0) IV, n (%) 5 (7.1)
Papilla located within a diverticulum, n (%) 4 (5.7)
Reason for randomization Failed initial cannulation, n (%) 35 (50.0) Papilla classification type, n (%) 21 (30.0) Papilla location, n (%) 14 (20.0)
|
No Forceps-assisted Cannulation
Those who underwent cannulation without forceps-assisted technique
n=81
Age, years (SD) 68.3 (13.3)
Gender Male, n (%) 32 (39.5) Female, n (%) 49 (60.5)
BMI, kg/m2 27.5
ERCP indication Choledocholithiasis, n (%) 37 (45.7) Extrahepatic malignant biliary obstruction, n (%) 19 (23.5) Intrahepatic malignant biliary obstruction, n (%) 4 (4.9) Chronic pancreatitis 2 (2.5) Sphincter of oddi dysfunction, n (%) 0 (0) Pancreatic stone disease, n (%) 0 (0) Bile leak, n (%) 4 (4.9) Pancreatic fistula, n (%) 1 (1.2) Dorsal duct intervention, n (%) 0 (0) Other, n (%) 14 (17.3)
Trainee involvement, n (%) 51 (63.0)
Papilla classification type I, n (%) 64 (79.0) II, n (%) 5 (6.2) III, n (%) 8 (9.9) IV, n (%) 4 (4.9)
Papilla located within a diverticulum, n (%) 8 (9.9)
Reason for randomization Failed initial cannulation, n (%) 45 (55.6) Papilla classification type, n (%) 11 (13.6) Papilla location, n (%) 25 (30.9)
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
81
|
|
Overall Study
COMPLETED
|
70
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Forceps-assisted Group
n=70 Participants
n=70
Age, years (SD) 61.9 (16.3)
Gender Male, n (%) 33 (47.1) Female, n (%) 37 (52.9)
BMI, kg/m2 29.3
ERCP indication Choledocholithiasis, n (%) 29 (41.4) Extrahepatic malignant biliary obstruction, n (%) 20 (28.6) Intrahepatic malignant biliary obstruction, n (%) 4 (5.7) Chronic pancreatitis 2 (2.9) Sphincter of oddi dysfunction, n (%) 0 (0) Pancreatic stone disease, n (%) 0 (0) Bile leak, n (%) 5 (7.1) Pancreatic fistula, n (%) 1 (1.4) Dorsal duct intervention, n (%) 1 (1.4) Other, n (%) 8 (11.4)
Trainee involvement, n (%) 43 (61.4)
Papilla classification type I, n (%) 45 (64.3) II, n (%) 6 (8.6) III, n (%) 14 (20.0) IV, n (%) 5 (7.1)
Papilla located within a diverticulum, n (%) 4 (5.7)
Reason for randomization Failed initial cannulation, n (%) 35 (50.0) Papilla classification type, n (%) 21 (30.0) Papilla location, n (%) 14 (20.0)
|
No Forceps-assisted Cannulation
n=81 Participants
n=81
Age, years (SD) 68.3 (13.3)
Gender Male, n (%) 32 (39.5) Female, n (%) 49 (60.5)
BMI, kg/m2 27.5
ERCP indication Choledocholithiasis, n (%) 37 (45.7) Extrahepatic malignant biliary obstruction, n (%) 19 (23.5) Intrahepatic malignant biliary obstruction, n (%) 4 (4.9) Chronic pancreatitis 2 (2.5) Sphincter of oddi dysfunction, n (%) 0 (0) Pancreatic stone disease, n (%) 0 (0) Bile leak, n (%) 4 (4.9) Pancreatic fistula, n (%) 1 (1.2) Dorsal duct intervention, n (%) 0 (0) Other, n (%) 14 (17.3)
Trainee involvement, n (%) 51 (63.0)
Papilla classification type I, n (%) 64 (79.0) II, n (%) 5 (6.2) III, n (%) 8 (9.9) IV, n (%) 4 (4.9)
Papilla located within a diverticulum, n (%) 8 (9.9)
Reason for randomization Failed initial cannulation, n (%) 45 (55.6) Papilla classification type, n (%) 11 (13.6) Papilla location, n (%) 25 (30.9)
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 16.3 • n=70 Participants
|
68.3 years
STANDARD_DEVIATION 13.3 • n=81 Participants
|
65.0 years
STANDARD_DEVIATION 15.0 • n=151 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=70 Participants
|
32 Participants
n=81 Participants
|
69 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=70 Participants
|
49 Participants
n=81 Participants
|
82 Participants
n=151 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
70 participants
n=70 Participants
|
81 participants
n=81 Participants
|
151 participants
n=151 Participants
|
|
BMI
|
29.3 kg/m^2
STANDARD_DEVIATION 7.4 • n=70 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 7.1 • n=81 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 7.2 • n=151 Participants
|
|
ERCP indication
Choledocholithiasis
|
29 Participants
n=70 Participants
|
37 Participants
n=81 Participants
|
66 Participants
n=151 Participants
|
|
ERCP indication
Extrahepatic malignant biliary obstruction
|
20 Participants
n=70 Participants
|
19 Participants
n=81 Participants
|
39 Participants
n=151 Participants
|
|
ERCP indication
Intrahepatic malignant biliary obstruction
|
4 Participants
n=70 Participants
|
4 Participants
n=81 Participants
|
8 Participants
n=151 Participants
|
|
ERCP indication
Chronic pancreatitis
|
2 Participants
n=70 Participants
|
2 Participants
n=81 Participants
|
4 Participants
n=151 Participants
|
|
ERCP indication
Sphincter of oddi dysfunction
|
0 Participants
n=70 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=151 Participants
|
|
ERCP indication
Pancreatic stone disease
|
0 Participants
n=70 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=151 Participants
|
|
ERCP indication
Bile leak
|
5 Participants
n=70 Participants
|
4 Participants
n=81 Participants
|
9 Participants
n=151 Participants
|
|
ERCP indication
Pancreatic fistula
|
1 Participants
n=70 Participants
|
1 Participants
n=81 Participants
|
2 Participants
n=151 Participants
|
|
ERCP indication
Dorsal duct intervention
|
1 Participants
n=70 Participants
|
0 Participants
n=81 Participants
|
1 Participants
n=151 Participants
|
|
ERCP indication
Other
|
8 Participants
n=70 Participants
|
14 Participants
n=81 Participants
|
22 Participants
n=151 Participants
|
|
Fellow involvement in ERCP procedure
|
43 Participants
n=70 Participants
|
51 Participants
n=81 Participants
|
94 Participants
n=151 Participants
|
|
Papilla morphologic classification type
I
|
45 Participants
n=70 Participants
|
64 Participants
n=81 Participants
|
109 Participants
n=151 Participants
|
|
Papilla morphologic classification type
II
|
6 Participants
n=70 Participants
|
5 Participants
n=81 Participants
|
11 Participants
n=151 Participants
|
|
Papilla morphologic classification type
III
|
14 Participants
n=70 Participants
|
8 Participants
n=81 Participants
|
22 Participants
n=151 Participants
|
|
Papilla morphologic classification type
IV
|
5 Participants
n=70 Participants
|
4 Participants
n=81 Participants
|
9 Participants
n=151 Participants
|
|
Reason for randomization
Failed initial cannulation
|
35 Participants
n=70 Participants
|
45 Participants
n=81 Participants
|
80 Participants
n=151 Participants
|
|
Reason for randomization
Papilla classification type
|
21 Participants
n=70 Participants
|
11 Participants
n=81 Participants
|
32 Participants
n=151 Participants
|
|
Reason for randomization
Papilla location
|
14 Participants
n=70 Participants
|
25 Participants
n=81 Participants
|
39 Participants
n=151 Participants
|
|
Papilla located within a diverticulum
|
4 Participants
n=70 Participants
|
8 Participants
n=81 Participants
|
12 Participants
n=151 Participants
|
PRIMARY outcome
Timeframe: Baseline (during the ERCP)A difficult cannulation will be defined as any cannulation that results in any of the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or more unintentional pancreatic wire passages.
Outcome measures
| Measure |
Forceps-assisted Group
n=70 Participants
Forceps used during cannulation
|
No Forceps-assisted Cannulation
n=81 Participants
No forceps used during cannulation
|
|---|---|---|
|
Cannulation Success Rate and Difficult Cannulation Rate
Successful cannulation
|
70 Participants
|
68 Participants
|
|
Cannulation Success Rate and Difficult Cannulation Rate
Unsuccessful cannulation
|
0 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 5 (+/- 2) days after ERCPOutcome measures
| Measure |
Forceps-assisted Group
n=70 Participants
Forceps used during cannulation
|
No Forceps-assisted Cannulation
n=81 Participants
No forceps used during cannulation
|
|---|---|---|
|
Number of Post-ERCP Pancreatitis (PEP)
|
4 Participants
|
3 Participants
|
Adverse Events
Forceps-assisted Group
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
No Forceps-assisted Cannulation
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Forceps-assisted Group
n=70 participants at risk
n=70
|
No Forceps-assisted Cannulation
n=81 participants at risk
n=81
|
|---|---|---|
|
Hepatobiliary disorders
PEP
|
5.7%
4/70 • Number of events 4 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
3.7%
3/81 • Number of events 3 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
Hepatobiliary disorders
Cholangitis
|
2.9%
2/70 • Number of events 2 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
Infections and infestations
Bacteremia
|
0.00%
0/70 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
Hepatobiliary disorders
Bile duct perforation
|
0.00%
0/70 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/70 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/70 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
General disorders
Enceophalopathy
|
0.00%
0/70 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
Other adverse events
| Measure |
Forceps-assisted Group
n=70 participants at risk
n=70
|
No Forceps-assisted Cannulation
n=81 participants at risk
n=81
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
2.5%
2/81 • Number of events 2 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
|
General disorders
Allergic reaction
|
1.4%
1/70 • Number of events 1 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
0.00%
0/81 • Adverse events were collected through the 5 +/- 2 day follow-up call.
Adverse events were collected via chart review and patient contact
|
Additional Information
Dr. Timothy B. Gardner
Dartmouth-Hitchcock Medical Center
Phone: 603-653-9033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place