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

NCT ID: NCT01887041

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-12-31

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.

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-operatively, 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 operation, to be used as co-variant.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Biliodigestive anastomosis

Intervention Type: PROCEDURE

Biliodigestive anastomosis

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.

Group Type: ACTIVE_COMPARATOR

Stent

Intervention Type: PROCEDURE

Endoscopically inserted biliary tract drainage

Interventions

Stent

Endoscopically inserted biliary tract drainage

Intervention Type: PROCEDURE

Biliodigestive anastomosis

Biliodigestive anastomosis

Intervention Type: PROCEDURE

Eligibility 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 endoscopic retrograde cholangio-pancreaticography (ERCP)-induced intervention.

2. Pregnancy

3. Breast feeding

4. Contra-indication for gemcitabine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob R Izbicki, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Hamburg

Locations

Universtätsklinik Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

1 - mtachezy

Identifier Type: -

Identifier Source: org_study_id