Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

NCT05297136 | Recruiting

• 1 other identifier: 2021.728-T
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatectomy; Pancreatic Fistula

Keywords

Distal Pancreatectomy; Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants developing post-operative morbidity

  90 days

• Number of participants developing post-operative mortality

  90 days

• Total length of hospital stay of participants

  90 days after endoscopy and operation

• Number of participants developing complications related to Endoscopic Retrograde Cholangiography

  14 days after endoscopy

Study Arms (2)

Pre-op Stenting

EXPERIMENTAL

Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy

Procedure: Pancreatic Stenting

Surgery alone

ACTIVE COMPARATOR

Distal pancreatectomy alone

Procedure: No Stent

Interventions

Pancreatic Stenting PROCEDURE

Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy

Pre-op Stenting

No Stent PROCEDURE

No preoperative stenting with distal pancreatectomy alone

Surgery alone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

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

Study Officials

• Kit Fai Lee, MBBS

  Clinical Associate Professor (honorary)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kit Fai Lee, MBBS

CONTACT

35051496; leekf@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor (honorary)

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 28, 2022
• Study Start: March 21, 2022
• Primary Completion: March 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)