Octreotide Microspheres for Preventing Pancreatic Fistula

NCT07479784 | Not Yet Recruiting Phase 3

• 1 other identifier: B2026-051R
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Fistula

Keywords

Pancreatic Fistula; Octreotide Microspheres; Distal Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of biochemical leak

  up to 60 days

• Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively

  up to 60 days

• Mortality rate at 60 days postoperatively

  up to 60 days

• Proportion of patients requiring rescue therapy

  up to 60 days

• Length of hospital stay

  up to 60 days

Study Arms (2)

Octreotide Microspheres

EXPERIMENTAL

Octreotide microspheres (Youyuan), 30 mg, intramuscular injection; administered 7 days before surgery.

Drug: Octreotide Microspheres

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Octreotide Microspheres DRUG

Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery

Octreotide Microspheres

Placebo DRUG

Control group: Placebo (normal saline), administered 7 days before surgery.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenquan Wang

CONTACT

+86 21 31587861; wang.wenquan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share