Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Not Applicable

• Conditions: Pancreatic Fistula
• Interventions: Device: Prophylactic pancreatic stent

• Registration Number: NCT03822676
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-22
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30
• Primary Completion: 2021-12
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria

• Subjects for whom ERCP procedures are contraindicated
• If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
• Age less than 18 year
• Emergency surgery
• Previous pancreatic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent	Prophylactic pancreatic stent	Prophylactic pancreatic stent before segmental pancreatic surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula	from postoperative day 3 to 30	Grade B and C

Secondary Outcome Measures

Name	Time	Method
Severity of pancreatic fistula	from postoperative day 3 to 30	Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
Length of stay	from postoperative day 1 to discharge	Length of hospital stay

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China