Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Not Applicable

Recruiting

• Conditions: Pancreatectomy; Pancreatic Fistula
• Interventions: Procedure: No Stent; Procedure: Pancreatic Stenting

• Registration Number: NCT05297136
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study Start: 2022-03-21
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Primary Completion: 2026-03-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery alone	No Stent	Distal pancreatectomy alone
Pre-op Stenting	Pancreatic Stenting	Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants developing complications related to Endoscopic Retrograde Cholangiography	14 days after endoscopy	All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded
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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong