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

NCT04965311 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: STUDY00022619NCI-2021-06239
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)

  Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.

  Up to postoperative day 30

Secondary Outcomes (2)

• Rate of Serious Adverse Event

  Prior to surgery up to 30 days post surgery (up to 3 months)

• Number of Participants With Any POPF

  Prior to surgery up to 30 days post surgery (up to 3 months)

Study Arms (1)

Treatment of POPF (botulinum toxin type A)

EXPERIMENTAL

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.

Biological: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A BIOLOGICAL

Given via endoscopic injection into intraduodenal sphincter of Oddi segment

Also known as: AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin, Botulinum Neurotoxin Type A, Botulinum Toxin A, BTX-A, DaxibotulinumtoxinA, Dysport, EvabotulinumtoxinA, IncobotulinumtoxinA, OnabotulinumtoxinA, Onaclostox, Prabotulinumtoxin A, Xeomin

Treatment of POPF (botulinum toxin type A)

Eligibility Criteria

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

You may qualify if:

• Participant scheduled for elective distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS), via open or laparoscopic technique
• Participant \>= 18 years of age
• Ability to understand nature and individual consequences of clinical trial
• Written informed consent from participant or legally authorized representative
• For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention

You may not qualify if:

• Known hypersensitivity to any BTX preparation or to any of the components in the formulation
• Infection at the proposed injection site, including cholangitis
• Anatomy incompatible with planned intervention (e.g., Roux-en-Y gastric bypass, distal gastrectomy with Roux-en-Y or Billroth II reconstruction)
• Acute pancreatitis within 2 weeks of planned study intervention
• American Society of Anesthesiologists (ASA) score \> III
• Serious cardiovascular disease (e.g., myocardial infarction in the past year, New York Heart Association \[NYHA\] III/IV congestive heart failure, unstable angina)
• Creatinine clearance \< 30 mL/min
• Liver cirrhosis (of any Child-Pugh grade)
• Neuromuscular or any neurological disease with associated increased risk for a participant undergoing BTX injection
• Prior BTX administration
• Inability to obtain informed consent due to comprehension or language barrier
• Inability to comply with study and/or follow-up procedures
• Pregnancy or lactation
• Any condition that could result in undue risk for the participant and/or influence outcome measures (in the opinion of the investigator)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA; prabotulinumtoxin A

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Brett Sheppard
• Organization: OHSU Knight Cancer Institute

sheppard@ohsu.edu

503-494-9169

Study Officials

• Brett C Sheppard, M.D., FACS

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: March 1, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Locations

US (1)