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

NCT00487851 | Withdrawn Phase 2 DMC

• 1 other identifier: 2006/2:3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Duodenal Neoplasms

Keywords

Pancreatic; cancer; Periampullay; Neoplasms; Biliary; Duodenal; Jaundice; obstruction; pancreas cancer; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Endoscopic treatment strategy

Procedure: endoscopic strategy

2

ACTIVE COMPARATOR

Surgical treatment strategy

Procedure: surgery

Interventions

surgery PROCEDURE

hepaticojejunostomy and gastroenterostomy

2

endoscopic strategy PROCEDURE

Stent insertion

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinksa university hospital

Huddinge, 14186, Sweden

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Duodenal Neoplasms; Neoplasms; Jaundice; Bites and Stings

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Farshad Frozanpor

  Karolinska institut Huddinge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

SE (1)