Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Pancreatic Cancer Periampullary Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double bypass

Group Type ACTIVE_COMPARATOR

Hepaticojejunostomy and gastroenterostomy

Intervention Type PROCEDURE

Standard surgical techniques

Stent Strategy

Group Type ACTIVE_COMPARATOR

Stent strategy

Intervention Type PROCEDURE

Biliary and/or enteral stents on demand

Interventions

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Hepaticojejunostomy and gastroenterostomy

Standard surgical techniques

Intervention Type PROCEDURE

Stent strategy

Biliary and/or enteral stents on demand

Intervention Type PROCEDURE

Other Intervention Names

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Biliodigestive anastomosis Gastrojenunal anastomosis Bile duct stent Gastroduodenal stent Enteral stent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No