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

NCT03174353 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00002777
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Leak; Pancreatic Fistula; Pancreaticoduodenal; Fistula; Pancreatectomy; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Combined Clinically Significant Postoperative Pancreatic Fistula and Intra-abdominal Abscess

  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.

  Measured throughout 60 days

Secondary Outcomes (2)

• Biochemical Leak (Grade A Postoperative Pancreatic Fistula)

  Measured throughout 60 days

• Overall Postoperative Morbidity

  Measured throughout 60 days

Study Arms (1)

Lanreotide arm

EXPERIMENTAL

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.

Drug: Lanreotide Prefilled Syringe

Interventions

Lanreotide Prefilled Syringe DRUG

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-surgical center 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.

Also known as: Somatuline Depot 120 Mg/0.5Ml Solution for Injection

Lanreotide arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients age ≥ 18 years
• Candidate for planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy
• Able to provide informed consent
• Able to adhere to dose and schedule of visits
• Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female subjects who are at risk of becoming pregnant must agree to use an effective method of contraception such as double barrier contraception, an injectable, combined oral contraceptive or an intra-uterine device (IUD). The subject must agree to use the contraception during the whole period of the study and for eight months after the last study drug administration. Non childbearing potential is defined as being postmenopausal for at least 1 year, or permanently sterilized at least 3 months before study entry.
• Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception.

You may not qualify if:

• Use of disallowed concomitant medications
• Has been treated with a Somatostatin analogs (SSA) at any time prior to planned study drug administration, except if that treatment was for less than 15 days of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to randomization
• Planned tumor enucleation or total pancreatectomy
• Pregnancy or breastfeeding
• Malabsorption syndrome, short bowel, or chologenic diarrhea uncontrolled by specific therapeutic interventions
• New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, sustained ventricular arrhythmia, advanced heart block, clinically significant bradycardia, or acute myocardial infarction within six months before enrollment
• Severe renal insufficiency as defined by a calculated creatinine clearance \<30 mL/min
• Known allergic reactions to components of the study drug
• Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization
• Treatment with systemic immunosuppressive medications, such as cyclosporine, tacrolimus, or prednisone (≥10 mg daily) within 3 months prior to dosing of study drug
• Treatment with another investigational drug within 10 days prior to dosing of study drug
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pancreatic Fistula; Fistula; Hyperglycemia

Interventions

lanreotide; Solutions; Injections

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Single arm Single center Small sample size

Results Point of Contact

• Title: Dr. Venu Pillarisetty
• Organization: University of Washington

vgp@uw.edu

206-616-4924

Study Officials

• Venu G Pillarisetty, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 2, 2017
• Study Start: February 20, 2018
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 16, 2022
• Results First Posted: June 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)