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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01887041
Recruitment Status : Terminated (Recruiting problems)
First Posted : June 26, 2013
Last Update Posted : February 8, 2016
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
Local Tumor Spread Advanced Cancer Metastasized Pancreatic Cancer Non-resectable Jaundice Procedure: Stent Procedure: Biliodigestive anastomosis Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Outcome of Quality of Life. [ Time Frame: 2 1/2 years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01887041

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Universtätsklinik Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Jacob R Izbicki, MD Universitätsklinik Hamburg
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01887041    
Other Study ID Numbers: 1 - mtachezy
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Advanced, metastasising pancreatic head carcinoma
Biliodigestive anastomosis
Endoscopically inserted biliary tract drainage
Quality of Life
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathologic Processes
Skin Manifestations