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

Study Overview

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

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

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%.

Pancreatic Neoplasms
Biliary Tract Neoplasms
Duodenal Neoplasms

PROCEDURE: surgery
PROCEDURE: endoscopic strategy

2006/2:3

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-06-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-04-11
First Submitted that Met QC Criteria 2007-06-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-04-12
First Posted (ESTIMATED) 2007-06-19	Results First Posted N/A	Last Verified 2013-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1 Endoscopic treatment strategy	PROCEDURE: endoscopic strategy Stent insertion
ACTIVE_COMPARATOR: 2 Surgical treatment strategy	PROCEDURE: surgery hepaticojejunostomy and gastroenterostomy

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 1

Endoscopic treatment strategy

PROCEDURE: endoscopic strategy

Stent insertion

ACTIVE_COMPARATOR: 2

Surgical treatment strategy

PROCEDURE: surgery

hepaticojejunostomy and gastroenterostomy

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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".

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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Farshad Frozanpor, Karolinska institut Huddinge

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record