Octreotide Microspheres for Preventing Pancreatic Fistula

A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Drug: Octreotide Microspheres; Drug: Placebo

Detailed Description

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy. Participants will be enrolled and allocated, with approximately 230 individuals expected to participate in this study conducted across three different medical institutions.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wenquan Wang; Phone Number: +86 21 31587861; Email: wang.wenquan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects voluntarily participate in this study and sign the informed consent form;
• Age ≥18 and ≤80 years old, both males and females are eligible;
• Preoperative imaging assessment indicates the corresponding disease is surgically resectable;
• Planned to undergo distal pancreatectomy;
• Female subjects of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug. A negative HCG test result within 7 days prior to initiating study treatment is required, and they must not be lactating;
• Male subjects with partners of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug; during the same period, male patients must also agree not to donate sperm.

Exclusion Criteria:

• Cirrhosis or chronic active hepatitis;
• Presence of malabsorption syndrome, short bowel syndrome, or choleretic diarrhea that cannot be effectively controlled;
• Acute cholecystitis;
• Uncontrolled infection, or history of immunodeficiency, including a positive HIV test;
• International Normalized Ratio (INR) >1.5, or use of medication affecting prothrombin time (PT) or activated partial thromboplastin time (APTT);
• Patients scheduled for total pancreatectomy;
• History of pancreatic resection surgery;
• Concurrent severe cardiac, pulmonary, hepatic, or renal disease making the patient unfit for surgery;
• Previous treatment with long-acting somatostatin analogues; treatment with somatostatin or short-acting somatostatin analogues within 5 half-lives;
• Known allergy to somatostatin or its analogues;
• Current participation in another clinical trial, except for observational, non-interventional studies or the follow-up period of an interventional study;
• Any condition that, in the investigator's judgment, may pose a risk to the subject from receiving the study drug, or may interfere with the evaluation of the study drug, subject safety, or interpretation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Control group: Placebo (normal saline), administered 7 days before surgery.
Experimental: Octreotide Microspheres; Octreotide microspheres (Youyuan), 30 mg, intramuscular injection; administered 7 days before surgery.	Drug: Octreotide Microspheres; Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CR-POPF at 60 days postoperatively	Incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) at 60 days postoperatively (according to the 2016 International Study Group on Pancreatic Surgery [ISGPS] criteria).	up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		up to 60 days
Incidence of biochemical leak	Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria).	up to 60 days
Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively	Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively (according to the 2022 Guidelines for Prevention and Management of Common Post-pancreatectomy Complications).	up to 60 days
Mortality rate at 60 days postoperatively		up to 60 days
Proportion of patients requiring rescue therapy		up to 60 days
Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0).		up to 60 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pancreatic Fistula; Distal Pancreatectomy; Octreotide Microspheres
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Signs and Symptoms; Pancreatic Fistula
• Other Study ID Numbers: B2026-051R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No