Pancreatic Stent for Distal Pancreatectomy

Shanghai Jiao Tong University

Status: Completed

Conditions: Distal Pancreatectomy

Treatments: Device: Pancreatic stent: PSOF COOK®

Study type: Interventional

Funder types: Other

Identifiers

NCT03314337

HBP-RCT-002

Details and patient eligibility

About

The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing distal pancreatectomy
2. Signed the informed consents

Exclusion criteria

1. Recurrence patients
2. pre-operative anti-cancer treatment
3. patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
4. AJCC stage IV
5. pre operative oddi'ssphincter incision
6. operation non radical
7. pancreatic stent not at place

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups

Distal Pancreatectomy without pancreatic stent

No Intervention group

Distal Pancreatectomy with pancreatic stent

Experimental group

Description:

pancreatic stent will be placed in the main pancreatic duct during the operation

Treatment:

Device: Pancreatic stent: PSOF COOK®