Clinical trial · Interventional
Quality of Life After Biliodigestive Anastomosis (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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruiting problems
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Jaundice | — | UNRESOLVED | — |
| Local Tumor Spread | — | UNRESOLVED | — |
| Metastasized | — | UNRESOLVED | — |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biliodigestive anastomosis | Procedure | — | UNRESOLVED |
| Stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stent
- description
- 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.
- interventionNames
- Procedure: Stent
- type
- ACTIVE_COMPARATOR
- label
- Biliodigestive anastomosis
- description
- 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.
- interventionNames
- Procedure: Biliodigestive anastomosis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available