Quality of Life After BDA or Stents to Treat Biliary Obstruction in Pancreas Cancer (BYPAPA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01887041
First received: June 24, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs. endoscopical stenting for palliation of biliary obstruction due to locally unresectable or metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on older studies, but with new chemotherapeutic regimens available, the likelihood to experience stent complications has increased. Therefore, the issue as to which palliation should be favoured has to be reconsidered.


Condition Intervention Phase
Local Tumor Spread
Advanced Cancer
Metastasized
Pancreatic Cancer Non-resectable
Jaundice
Procedure: Stent
Procedure: Biliodigestive anastomosis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Outcome of Quality of Life. [ Time Frame: 2 1/2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence of surgical complications and complications, with regard to the endo-scopic stent insertion, are further aspects that shall be examined in this study. [ Time Frame: 2 1/2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: January 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stent
Arm B, after randomisation the biliary tract stents shall remain. The patients in study arm B will also receive chemotherapy and gemcitabine, according to the recommended palliative therapy for a pancreas carcinoma.
Procedure: Stent
Endoscopically inserted biliary tract drainage
Active Comparator: Biliodigestive anastomosis

Study arm A will, after randomisation, have a biliodigestive anastomosis inserted. After the healing of the wound (al least 14 days postoperative) the treatment using gemcitabine, according to the plan mentioned below.

Gemcitabine shall be administered on days 1, 8 and 15 of each 4 week cycle. The cycle is defined as a weekly, over a period of 3 consecutive weeks, applied infusions, followed by 1 week pause. On the day of therapy a dosage of 1000 mg/ml body surface shall be administered, intravenous, over a period of 30 minutes.

Procedure: Biliodigestive anastomosis
Biliodigestive anastomosis

Detailed Description:

The aim of this multi-centre, prospective-randomised study was to compare the effectiveness of palliative applications on patients suffering from a local, advanced and/or hepatic, metastasising, non-resectable pancreas head carcinoma and jaundice.

Before randomisation, all patients are fitted with an endoscopically inserted biliary tract drainage endoscopically inserted. When postoperatively ascertained that the pancreas head carcinoma is non-resectable, the patient shall be electronically registered and randomly assigned to one of the palliative strategies. Group 1 will be fitted with a biliodigestive anastomosis. Group 2 will continue with the endoscopically inserted drainage. Regardless of which group they belong to, all patients will receive a palliative chemotherapy.

The primary parameter is the average quality of life over a period of 6 months post-OP, to be analysed monthly using identical questionnaires. The comparison of the randomisation groups will be carried out using a co-variance analysis (ANCOVA) with the initial value, taken directly before the OP, to be used as co-variant.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice.
  2. Performance-status of 50 or above on the Karnofsky-scale (see attachment).
  3. Adequate bone marrow reserves: leukocyte level > 3.5 x 10´/l, thrombocyte level level > 100 x 10/l; Haemoglobin> 80g/l.
  4. Male or female patients, at least 18 years old.
  5. Women of child bearing age must be sufficient protected against pregnancy (contraception) during and for 3 months after the end of the study.

Exclusion Criteria:

  1. Adult patients with focal, advanced adenocarcinoma of the pancreas head and no jaundice; also no jaundice in their anamnesis and with no ERCP-induced intervention.
  2. Pregnancy
  3. Breast feeding
  4. Contra-indication for gemcitabine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887041

Contacts
Contact: Jacob R Izbicki, MD +4949741052401 izbicki@uke.de
Contact: Maximilian Bockhorn, MD +4940741052401 m.bockhorn@uke.uni-hamburg.de

Locations
Germany
Universtätsklinik Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Jacob R Izbicki, MD    +4940741052401    izbicki@uke.de   
Principal Investigator: Jacob R Izbicki, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Jacob R Izbicki, MD Universitätsklinik Hamburg
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01887041     History of Changes
Other Study ID Numbers: 1 - mtachezy
Study First Received: June 24, 2013
Last Updated: June 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Advanced, metastasising pancreatic head carcinoma
Jaundice
Biliodigestive anastomosis
Endoscopically inserted biliary tract drainage
Quality of Life

Additional relevant MeSH terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Neoplastic Processes
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014