NCT03174353

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

Completed Phase 2 Results posted Last updated 16 June 2022

What this trial tests

Phase 2 trial testing Lanreotide Prefilled Syringe in Pancreatic Leak in 114 participants. Completed in 1 April 2021.

Timeline

20 February 2018

Primary endpoint
1 February 2021

1 April 2021

Quick facts

Lead sponsor	University of Washington
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	114
Start date	20 February 2018
Primary completion	1 February 2021
Estimated completion	1 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Lanreotide Prefilled Syringe — full drug profile →

Conditions studied

• Pancreatic Leak — all drugs for Pancreatic Leak →
• Pancreatic Fistula — all drugs for Pancreatic Fistula →
• Pancreaticoduodenal; Fistula — all drugs for Pancreaticoduodenal; Fistula →
• Pancreatectomy; Hyperglycemia — all drugs for Pancreatectomy; Hyperglycemia →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Pancreatic Leak or Pancreatic Fistula. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Combined Clinically Significant Postoperative Pancreatic Fistula and Intra-abdominal Abscess Primary · Measured throughout 60 days

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 detec

Group	Value	95% CI
Lanreotide Arm	8

Biochemical Leak (Grade A Postoperative Pancreatic Fistula) Secondary · 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.

Group	Value	95% CI
Lanreotide Arm	12

Overall Postoperative Morbidity Secondary · 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.

Group	Value	95% CI
Lanreotide Arm	26

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event were collected up to 60 days following operation.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lanreotide Arm

Serious: 8/98 (8%)

Deaths: 0/98

Serious adverse events (1 terms)

Reaction	System	Lanreotide Arm
Clinically significant postoperative pancreatic fistula	Surgical and medical procedures	—

Other adverse events (1 terms — click to expand)

Reaction	System	Lanreotide Arm
Drug-related adverse event	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Clinically significant postoperative pancreatic fistula.

Data from ClinicalTrials.gov NCT03174353 adverse events section.

Sponsor's own description

This is a single arm investigator-initiated study designed to test the feasibility and potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or pancreatic leak and fistula. All consenting patients undergoing planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will be treated with a single deep subcutaneous dose of lanreotide prior to planned resection on the day of surgery. Following this intervention, care will be based on standard treatment protocols. Sixty-day mortality and morbidity will be collected for all patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.