Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Study Overview
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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.

Official Title
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Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Conditions
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Pancreatic Cancer, Periampullary Tumor

Intervention / Treatment
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* Procedure: Hepaticojejunostomy and gastroenterostomy
* Procedure: Stent strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double bypass<br> | Procedure: Hepaticojejunostomy and gastroenterostomy<br>* Standard surgical techniques<br>* Other names: Gastrojenunal anastomosis;|
| Active Comparator: Stent Strategy<br> | Procedure: Stent strategy<br>* Biliary and/or enteral stents on demand<br>* Other names: Enteral stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification. | Day 1-30 after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries | Preop, 1 month postop and every third month | 
| Numbers of readmissions to hospital |  | Up to two years after the laparotomy | 
| The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions | The numbers of surgical, radiological or endoscopical interventions due to jaundice or gastric outlet obstruction from date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months | Up to 24 months after the randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent