NCT07479784

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
DRUG	Octreotide Microspheres	Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery
DRUG	Placebo	Control group: Placebo (normal saline), administered 7 days before surgery.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-18
• Last updated: 2026-03-18