Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer

Study Overview
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Brief Summary
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Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed Description
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Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Official Title
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Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer

Conditions
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Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms

Intervention / Treatment
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* Procedure: surgery
* Procedure: endoscopic strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction. The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as reasonable and both treatment strategies are considered applicable. Exclusion Criteria: Non consent. The patients' general condition will not tolerate either treatment (strategy). Previous laparotomy or laparoscopy. Life expectancy < 3 months. Inability to participate (language, social, etc.)
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Endoscopic treatment strategy | Procedure: endoscopic strategy<br>* Stent insertion<br>|
| Active Comparator: 2<br>Surgical treatment strategy | Procedure: surgery<br>* hepaticojejunostomy and gastroenterostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden. |  | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic, cancer, Periampullay, Neoplasms, Biliary, Duodenal, Jaundice, obstruction, pancreas cancer, Pancreatic cancer