Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05297136

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatectomy Pancreatic Fistula	Procedure: Pancreatic Stenting Procedure: No Stent	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Mar 20, 2026

Anticipated Study Completion Date :

May 20, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants with postoperative pancreatic fistula [Day 3 after operation]
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

Secondary Outcome Measures

Number of participants developing post-operative morbidity [90 days]
Post-operative complications, graded according to the Clavien-Dindo classification, are recorded
Number of participants developing post-operative mortality [90 days]
All cause mortality after operation was recorded
Total length of hospital stay of participants [90 days after endoscopy and operation]
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
Number of participants developing complications related to Endoscopic Retrograde Cholangiography [14 days after endoscopy]
All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Kit Fai Lee, MBBS, Clinical Associate Professor (honorary)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cheung Yue Sun, Clinical Associate Professor (honorary), Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05297136

Other Study ID Numbers:

2021.728-T

First Posted:

Mar 28, 2022

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cheung Yue Sun, Clinical Associate Professor (honorary), Chinese University of Hong Kong

Distal Pancreatectomy

Pancreatic Fistula

Additional relevant MeSH terms:

Pancreatic Fistula

Fistula

Study Results

No Results Posted as of Mar 28, 2022