NCT05297136

Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatectomy
• Pancreatic Fistula

Interventions

Type	Name	Description
PROCEDURE	Pancreatic Stenting	Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
PROCEDURE	No Stent	No preoperative stenting with distal pancreatectomy alone

Timeline

• Start date: 2022-03-21
• Primary completion: 2026-03-20
• Completion: 2026-05-20
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

1 site across 1 country: Hong Kong