Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial

Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula; Pancreatectomy
• Intervention / Treatment: Procedure: Pancreatic Stenting; Procedure: No Stent

Detailed Description

A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kit Fai Lee, MBBS; Phone Number: 35051496; Email: leekf@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Kit Fai Lee, MBBS; Phone Number: 35051496; Email: leekf@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years
• Elective distal pancreatectomy for primary pancreatic pathology

Exclusion Criteria:

• Informed consent not available
• Emergency distal pancreatectomy
• Presence of pancreatic duct stricture
• Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
• History of severe pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pre-op Stenting; Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy	Procedure: Pancreatic Stenting; Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
ACTIVE_COMPARATOR: Surgery alone; Distal pancreatectomy alone	Procedure: No Stent; No preoperative stenting with distal pancreatectomy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with postoperative pancreatic fistula	The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3	Day 3 after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants developing post-operative morbidity	Post-operative complications, graded according to the Clavien-Dindo classification, are recorded	90 days
Number of participants developing post-operative mortality	All cause mortality after operation was recorded	90 days
Total length of hospital stay of participants	The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation	90 days after endoscopy and operation
Number of participants developing complications related to Endoscopic Retrograde Cholangiography	All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded	14 days after endoscopy

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2022
• Primary Completion (ANTICIPATED): March 20, 2026
• Study Completion (ANTICIPATED): May 20, 2026

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (ACTUAL): March 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatic Fistula; Distal Pancreatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: 2021.728-T

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