Trial Outcomes & Findings for A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula (NCT NCT03174353)

NCT ID: NCT03174353

Last Updated: 2022-06-16

Results Overview

Reduction in the incidence of intraabdominal abscess or development of clinically significant (grade B or C) pancreatic fistula within 60 postoperative days. The grading of the primary outcome measure is based on a method published by the International Study Group of Pancreatic Surgery (ISGPS) in 2005 and then revised in 2016. As this study was developed prior to the revision, the 2005 version was used. This system for grading pancreatic fistula is based on progressively increasing severity of the complication from grade A to C. Grade Grade A fistula are characterized by elevated amylase detected within fluid coming from drain(s) placed at the time of surgery. Grade B fistula require change in patient management such as need for drain placement or institution of antimicrobial therapy, while grade C fistula are associated with severe clinical signs or symptoms such as sepsis. Please refer to page 12 of the study protocol for further details.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 114 participants
• Primary outcome timeframe: Measured throughout 60 days
• Results posted on: 2022-06-16

Participant Flow

Eligible patients were recruited in the clinic, between February 2018 and February 2021.

Participant milestones

Measure	Lanreotide Arm Single arm study. A single deep subcutaneous dose of lanreotide (Somatuline Depot 120 Mg/0.5Ml) will be administered prior to planned resection on the day of surgery. Lanreotide Prefilled Syringe: All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-operative area at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock.
Overall Study STARTED	114
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

Baseline characteristics by cohort

Measure	Lanreotide Arm n=98 Participants Single arm study. A single deep subcutaneous dose of lanreotide (Somatuline Depot 120 Mg/0.5Ml) will be administered prior to planned resection on the day of surgery. Lanreotide Prefilled Syringe: All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-operative area at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured throughout 60 days

Population: Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy

Reduction in the incidence of intraabdominal abscess or development of clinically significant (grade B or C) pancreatic fistula within 60 postoperative days. The grading of the primary outcome measure is based on a method published by the International Study Group of Pancreatic Surgery (ISGPS) in 2005 and then revised in 2016. As this study was developed prior to the revision, the 2005 version was used. This system for grading pancreatic fistula is based on progressively increasing severity of the complication from grade A to C. Grade Grade A fistula are characterized by elevated amylase detected within fluid coming from drain(s) placed at the time of surgery. Grade B fistula require change in patient management such as need for drain placement or institution of antimicrobial therapy, while grade C fistula are associated with severe clinical signs or symptoms such as sepsis. Please refer to page 12 of the study protocol for further details.

Outcome measures

Measure	Lanreotide Arm n=98 Participants Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
Combined Clinically Significant Postoperative Pancreatic Fistula and Intra-abdominal Abscess	8 Participants

SECONDARY outcome

Timeframe: Measured throughout 60 days

Grade A pancreatic fistula will be defined based on principles noted in evaluation of Primary endpoint. Grade A fistula are characterized by elevated amylase detected within fluid coming from drain(s) placed at the time of surgery, but do not cause deviation from standard post-operative recovery.

Outcome measures

Measure	Lanreotide Arm n=98 Participants Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
Biochemical Leak (Grade A Postoperative Pancreatic Fistula)	12 Participants

SECONDARY outcome

Timeframe: Measured throughout 60 days

Overall morbidity was defined based on the National Surgical Quality Improvement Program (NSQIP) templates. This measure counts the number of participants who had a complication during the 60-day study period.

Outcome measures

Measure	Lanreotide Arm n=98 Participants Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
Overall Postoperative Morbidity	26 Participants

Adverse Events

Lanreotide Arm

Serious events: 8 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lanreotide Arm n=98 participants at risk Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
Surgical and medical procedures Clinically significant postoperative pancreatic fistula	8.2% 8/98 • Number of events 8 • The adverse event were collected up to 60 days following operation.

Other adverse events

Measure	Lanreotide Arm n=98 participants at risk Patients undergoing pancreaticoduodencectomy or distal pancreatectomy for malignancy or suspected malignancy
Skin and subcutaneous tissue disorders Drug-related adverse event	2.0% 2/98 • Number of events 2 • The adverse event were collected up to 60 days following operation.

Additional Information

Dr. Venu Pillarisetty

University of Washington

Phone: 206-616-4924

Email: vgp@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place