Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Göteborg University

Status: Withdrawn

Conditions: Periampullary Tumor; Pancreatic Cancer

Treatments: Procedure: Stent strategy; Procedure: Hepaticojejunostomy and gastroenterostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01569282

Double bypass vs Stent

Details and patient eligibility

About

Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Preoperatively

   • Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy
   • The patient jaundice should have worn off and there should be no signs of duodenal obstruction
   • The patient has given informed consent after verbal and written information in accordance with approved ethics application
   • The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass.

2. Intraoperatively

   • Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery
   • Surgical double bypass should be technically feasible
   • The patient has given informed consent after verbal and written information in accordance with approved ethics application

Exclusion criteria

• Peroperative signs of dysfunction on biliary stent
• Peroperative findings of gastric outlet obstruction
• Surgical double bypass not technically feasible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Double bypass

Active Comparator group

Treatment:

Procedure: Hepaticojejunostomy and gastroenterostomy

Stent Strategy

Active Comparator group

Treatment:

Procedure: Stent strategy