Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297136
• Other study ID #: 2021.728-T
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: May 20, 2026

Study information

• Verified date: March 2022
• Source: Chinese University of Hong Kong
• Contact: Kit Fai Lee, MBBS
• Phone: 35051496
• Email: leekf[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 20, 2026
• Est. primary completion date: March 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatectomy
• Pancreatic Fistula

Intervention

Procedure:
• Pancreatic Stenting
Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
• No Stent
No preoperative stenting with distal pancreatectomy alone

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants developing post-operative morbidity	Post-operative complications, graded according to the Clavien-Dindo classification, are recorded	90 days
Secondary	Number of participants developing post-operative mortality	All cause mortality after operation was recorded	90 days
Secondary	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
Secondary	Number of participants developing complications related to Endoscopic Retrograde Cholangiography	All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded	14 days after endoscopy