Clinical trial · Interventional
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results. This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Drainage | — | UNRESOLVED | — |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Malignant Biliary Obstruction | — | UNRESOLVED | — |
| Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suprapapillary plastic stent placement | Procedure | — | UNRESOLVED |
| Transpapillary plastic stent placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Suprapapillary plastic stent (iPS)
- description
- Endoscopic placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent), with the distal end positioned within the bile duct and the sphincter of Oddi preserved, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction.
- interventionNames
- Procedure: Suprapapillary plastic stent placement
- type
- ACTIVE_COMPARATOR
- label
- Transpapillary plastic stent (tPS)
- description
- Endoscopic placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction.
- interventionNames
- Procedure: Transpapillary plastic stent placement
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Unresectable high-grade malignant hilar biliary obstruction (Bismuth type II, III, or IV) diagnosed by CT, MRI, and/or previous surgical specimen * Need for biliary drainage due to biliary obstruction (serum total bilirubin ≥2 mg/dL or diagnosis of cholangitis) * Life expectancy greater than 3 months * No stent previously placed in the biliary system * Written informed consent for participation in the study Exclusion Criteria: * Condition not allowing endoscopic intervention * Failed biliary cannulation * Surgically altered anatomy of the upper gastrointestinal tract, excluding Billroth-I reconstruction * Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis * Previous placement of external biliary drainage (e.g., percutaneous transhepatic biliary drainage) * Primary sclerosing cholangitis, immunoglobulin G4-associated cholangitis, or primary biliary cholangitis * Pregnancy * Patients who opt for self-paid metal stent placement and are judged suitable for metal stents by the treating physician
References
Publications (5)
- BACKGROUNDAngsuwatcharakon P, Kulpatcharapong S, Chuncharunee A, Khor C, Devereaux B, Moon JH, Ratanachu-Ek T, Wang HP, Pausawasdi N, Maydeo A, Itoi T, Ponnudurai R, Ramchandani M, Nakai Y, Seo DW, Ogura T, Tang RS, Kongkam P, Makmun D, Dy F, Ridtitid W, Kuo YT, Pham KC, Oung B, Lee J, Rerknimitr R. The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction. Endosc Int Open. 2024 Sep 16;12(9):E1065-E1074. doi: 10.1055/a-2366-7302. eCollection 2024 Sep. PMID 39285860
- BACKGROUNDKovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898. PMID 36769545
- BACKGROUNDKanno Y, Ito K, Nakahara K, Kawaguchi S, Masaki Y, Okuzono T, Kato H, Kuwatani M, Ishii S, Murabayashi T, Hasegawa S, Nagahama M, Iwashita Y, Michikawa Y, Terada S, Kawakami Y, Fujii Y, Kawakubo K. Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial. Gastrointest Endosc. 2023 Aug;98(2):211-221.e3. doi: 10.1016/j.gie.2023.03.007. Epub 2023 Mar 11. PMID 36907528
- BACKGROUNDKurita A, Uza N, Asada M, Yoshimura K, Takemura T, Yazumi S, Kodama Y, Seno H. Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction. Surg Endosc. 2022 May;36(5):2869-2878. doi: 10.1007/s00464-021-08576-x. Epub 2021 Jun 2. PMID 34076770
- RESULTPedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0. PMID 9852446