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

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ClinicalTrials.gov Identifier: NCT01887041
Recruitment Status : Terminated (Recruiting problems)
First Posted : June 26, 2013
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

June 24, 2013
June 26, 2013
February 8, 2016
January 2010
December 2015   (Final data collection date for primary outcome measure)
Outcome of Quality of Life. [ Time Frame: 2 1/2 years ]
Same as current
Complete list of historical versions of study NCT01887041 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Quality of Life After BDA or Stents to Treat Biliary Obstruction in Pancreas Cancer
Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Local Tumor Spread
  • Advanced Cancer
  • Metastasized
  • Pancreatic Cancer Non-resectable
  • Jaundice
  • Procedure: Stent
    Endoscopically inserted biliary tract drainage
  • Procedure: Biliodigestive anastomosis
    Biliodigestive anastomosis
  • 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.
    Intervention: Procedure: Stent
  • 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.

    Intervention: Procedure: Biliodigestive anastomosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
128
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01887041
1 - mtachezy
Yes
Not Provided
Plan to Share IPD: Undecided
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Not Provided
Principal Investigator: Jacob R Izbicki, MD Universitätsklinik Hamburg
Universitätsklinikum Hamburg-Eppendorf
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP