Clinical trial · Interventional
Endoscopic Versus Percutaneous Drainage For Hilar Block in Gall Bladder Cancer
Endoscopic Versus Percutaneous Biliary Drainage For Hilar Block Due to Carcinoma Gall Bladder: A Randomized Prospective Trial and Quality Of Life Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cancer of the gallbladder (CaGB) is one of the most common causes of malignant obstructive jaundice. Jaundice is the second most common presentation and occurs in 30-60% of patients with CaGB. It is obstructive in nature and frequently associated with pruritus, which is very disturbing for the patients. The usual mechanism of obstruction is direct infiltration of the bile duct by the tumour. Most patients with CaGB with obstructive jaundice are not amenable to a curative surgical resection and hence effective palliation is the goal of treatment. Although surgical bypass has been the traditional palliative approach, it is associated with substantial morbidity and mortality. Non-operative alternatives in the form of percutaneous and endoscopic drainage are available. A few trials have shown that endoscopic drainage is better than percutaneous drainage in patients with lower end bile duct obstruction due to pancreatic and peri-ampullary cancer. However, the scenario is quite different in patients with upper end of bile duct obstruction as occurs due to CaGB. Endoscopic drainage is associated with a higher incidence of cholangitis in patients with a block at the upper end of the bile duct and the success rate varies from 40% to 80%, while percutaneous drainage may be associated with complications such as biliary leak and bleeding. There has been no randomized trial comparing endoscopic and percutaneous drainage in patients with malignant obstruction due to CaGB. The objective of the present study is to carry out a randomized prospective trial comparing percutaneous and endoscopic biliary drainage in patients with CaGB with obstructive jaundice and to assess their quality of life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic biliary stenting, Percutaneous biliary stenting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PTBD
- description
- percutaneous biliary drainage
- interventionNames
- Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic stenting
- description
- ERCP and stenting
- interventionNames
- Procedure: Endoscopic biliary stenting, Percutaneous biliary stenting
Primary outcomes (3)
- measure
- Successful drainage: A decrease in bilirubin to less than 75% of the pretreatment value within 7 days
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * CaGB with hilar block not suitable for curative resection with one or more of the following criteria: * Jaundice with serum bilirubin \>10 mg/dl, * Pruritus, * Cholangitis Exclusion Criteria: * Poor performance status: Karnofsky index \< 60, * Type 1 and 4 hilar block, * Uncontrolled ascites, * Duodenal obstruction, * Patients who opted for insertion of a metallic stent.
References
Publications (2)
- BACKGROUNDSpeer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4. PMID 2439854
- BACKGROUNDPinol V, Castells A, Bordas JM, Real MI, Llach J, Montana X, Feu F, Navarro S. Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial. Radiology. 2002 Oct;225(1):27-34. doi: 10.1148/radiol.2243011517. PMID 12354980