Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pancreatic Fistula

Treatments: Device: Prophylactic pancreatic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03822676

ZS-1833

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Stent

Experimental group

Description:

Prophylactic pancreatic stent before segmental pancreatic surgery

Treatment:

Device: Prophylactic pancreatic stent

No stent

No Intervention group

Description:

No prophylactic stent before surgery