NCT04965311

Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy

A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effect of botulinum toxin (Botox) in preventing postoperative pancreatic fistula after distal pancreatectomy. Postoperative pancreatic fistula (POPF) is a known risk of distal pancreatic surgery, in which leakage of pancreatic digestive liquids causes internal swelling that can be painful (termed inflammation). A valve-like muscle, called the Sphincter of Oddi, opens and closes, controlling the flow of digestive liquids from the liver (bile) and pancreas (pancreatic juice) to the small intestine (duodenum). After surgery, the Sphincter of Oddi may act to block the flow of normal pancreatic secretions, causing secretions to leak into the abdomen resulting in POPF. Botox is a drug that can cause paralysis of muscles. Giving an injection of Botox into the sphincter of Oddi before distal pancreatic surgery may reduce leakage of digestive fluids and potential POPF.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF. SECONDARY OBJECTIVES: I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi. II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF. EXPLORATORY OBJECTIVES: I. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in POPF. II. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in clinically relevant POPF (crPOPF). III. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in postoperative length of hospital stay. IV. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of Clavien-Dindo grade III or greater complications. V. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of percutaneous drainage. VI. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of unplanned re-operation. OUTLINE: Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection. Patients are followed for 30 days following distal pancreas resection.

Conditions

• Pancreatic Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum Toxin Type A	Given via endoscopic injection into intraduodenal sphincter of Oddi segment

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2021-07-16
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study