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

NCT01887041 | Terminated Phase 4 DMC

• 1 other identifier: 1 - mtachezy
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Tumor Spread; Advanced Cancer; Metastasized; Pancreatic Cancer Non-resectable; Jaundice

Keywords

Advanced, metastasising pancreatic head carcinoma; Jaundice; Biliodigestive anastomosis; Endoscopically inserted biliary tract drainage; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Outcome of Quality of Life.

  2 1/2 years

Secondary Outcomes (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.

  2 1/2 years

Study Arms (2)

Stent

ACTIVE COMPARATOR

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

Biliodigestive anastomosis

ACTIVE COMPARATOR

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

Interventions

Stent PROCEDURE

Endoscopically inserted biliary tract drainage

Stent

Biliodigestive anastomosis PROCEDURE

Biliodigestive anastomosis

Biliodigestive anastomosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Adult patients with focal, advanced adenocarcinoma of the pancreas head and no jaundice; also no jaundice in their anamnesis and with no endoscopic retrograde cholangio-pancreaticography (ERCP)-induced intervention.
• Pregnancy
• Breast feeding
• Contra-indication for gemcitabine

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universtätsklinik Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Jaundice

Interventions

Stents

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jacob R Izbicki, MD

  Universitätsklinik Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)