Clinical trial · Interventional
Stenting Malignant Jaundice for Quality of Life
Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life
- 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)
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Neoplasms Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP with 10 French biliary plastic stent placement | Procedure | — | UNRESOLVED |
| ERCP with 11.5 French biliary plastic stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 10 French Stent
- description
- 10 French biliary plastic stent
- interventionNames
- Procedure: ERCP with 10 French biliary plastic stent placement
- type
- ACTIVE_COMPARATOR
- label
- 11.5 French stent
- description
- 11.5 French biliary plastic stent
- interventionNames
- Procedure: ERCP with 11.5 French biliary plastic stent
Primary outcomes (1)
- measure
- Documented change in Quality Of Life
- timeFrame
- 180 days after stent insertion
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with suspected or proven malignant biliary obstruction who were unresectable or inoperable and were undergoing ERCP and biliary stenting for biliary depression. Exclusion Criteria: * Had previously undergone biliary stenting * Surgery was planned * A guidewire could not be passed through the stricture * Suspected survival of \< 3 months * Impending duodenal obstruction
References
Publications (37)
- BACKGROUNDJemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23. PMID 11814064
- BACKGROUNDLowy AM. From bad to worse: prognostic factors in pancreatic cancer. Ann Surg Oncol. 2004 Feb;11(2):117-8. doi: 10.1245/aso.2004.12.930. No abstract available. PMID 14761910
- BACKGROUNDLowenfels AB, Maisonneuve P, Boyle P (1998) Epidemiology of pancreatic cancer. In: Howard J, Idezuki Y, Ihse I, Prinz R, eds. Surgical Diseases of the Pancreas. 3rd ed. Baltimore: Williams & Wilkins, 433-439
- 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
- BACKGROUNDAndersen JR, Sorensen SM, Kruse A, Rokkjaer M, Matzen P. Randomised trial of endoscopic endoprosthesis versus operative bypass in malignant obstructive jaundice. Gut. 1989 Aug;30(8):1132-5. doi: 10.1136/gut.30.8.1132. PMID 2475392
- BACKGROUNDMotte S, Deviere J, Dumonceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology. 1991 Nov;101(5):1374-81. doi: 10.1016/0016-5085(91)90091-x. PMID 1936809
- BACKGROUNDTarnasky PR, Cunningham JT, Hawes RH, Hoffman BJ, Uflacker R, Vujic I, Cotton PB. Transpapillary stenting of proximal biliary strictures: does biliary sphincterotomy reduce the risk of postprocedure pancreatitis? Gastrointest Endosc. 1997 Jan;45(1):46-51. doi: 10.1016/s0016-5107(97)70301-8. PMID 9013169
- BACKGROUNDMargulies C, Siqueira ES, Silverman WB, Lin XS, Martin JA, Rabinovitz M, Slivka A. The effect of endoscopic sphincterotomy on acute and chronic complications of biliary endoprostheses. Gastrointest Endosc. 1999 Jun;49(6):716-9. doi: 10.1016/s0016-5107(99)70288-9.