Clinical trial · Interventional
A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors
A Multicenter Randomized Trial of Percutaneous Transhepatic Biliary Drainage vs. Endoscopic Retrograde Cholangiography for Decompression of Suspected Malignant Biliary Hilar Obstruction - the INTERCPT Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual; recommended by DSMB.
Summary
Brief summary (as posted)
The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.
Conditions
Conditions (3)
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 Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hilar Lymphadenopathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERC | Procedure | — | UNRESOLVED |
| PTBD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Percutaneous Transhepatic Drainage
- description
- Subjects randomized to this arm will undergo PTBD as the first drainage intervention.
- interventionNames
- Procedure: PTBD
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic Retrograde Cholangiography
- description
- Subjects randomized to this arm will undergo ERC as the first drainage intervention.
- interventionNames
- Procedure: ERC
Primary outcomes (1)
- measure
- Successful biliary drainage
- timeFrame
- 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥40 (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis) 2. Cholestatic liver function tests, including serum alkaline phosphatase level ≥ 300 IU/L and bilirubin level ≥ 3.7 mg/dL 3. Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation Exclusion Criteria: 1. Known radiographic evidence of a Bismuth-Corlette type 1 biliary stricture 2. Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture 3. Recent gallbladder/biliary surgery within 12 months 4. Known Mirizzi syndrome 5. Known IgG4-mediated cholangiopathy 6. Significant liver metastatic disease interfering with safe/effective PTBD 7. Significant ascites interfering with safe/effective PTBD 8. Known regional malignant-appearing adenopathy or extra-biliary mass, indicating the need for concurrent EUS-FNA 9. Prior ERCP or PTBD for hilar obstruction 10. Surgically altered luminal anatomy other than prior Billroth reconstruction or Whipple resection 11. Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy, etc.) 12. Inability or unwillingness to follow study protocol
References
Publications (1)
- DERIVEDAl-Kawas F, Aslanian H, Baillie J, Banovac F, Buscaglia JM, Buxbaum J, Chak A, Chong B, Cote GA, Draganov PV, Dua K, Durkalski V, Elmunzer BJ, Foster LD, Gardner TB, Geller BS, Jamidar P, Jamil LH, Keswani RN, Khashab MA, Lang GD, Law R, Lichtenstein D, Lo SK, McCarthy S, Melo S, Mullady D, Nieto J, Bayne Selby J, Singh VK, Spitzer RL, Strife B, Tarnaksy P, Taylor JR, Tokar J, Wang AY, Williams A, Willingham F, Yachimski P; In alphabetical order for the INTERCPT Study Group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial. Trials. 2018 Feb 14;19(1):108. doi: 10.1186/s13063-018-2473-2. PMID 29444707