Neoplasms

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Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Patients randomized to this arm will undergo biliary stenting only

Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting

Endoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured.

Endoluminal radiofrequency ablation

Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.

Endoscopic biliary stenting

This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.

This clinical trial proposes a personalized treatment approach to inoperable perihilar cholangiocarcinoma consisting of endoluminal ablative therapy via radiofrequency ablation followed by endoscopic biliary drainage.

Patients presenting with jaundice / biliary obstruction caused by inoperable perihilar cholangiocarcinoma as assessed during multidisciplinary case discussion will be invited to enroll in this trial.

Patients will be randomized in a 1:1 fashion to receive biliary plastic stenting (control arm) or biliary plastic stenting + radiofrequency ablation via endoscopic approach. In cases where ERCP fails to achieve adequate biliary drainage, stenting and/or drainage will be attempted via percutaneous approach.

Additional systemic chemotherapy will be offered to all eligible patients according to the local standard of care.

Patients will be followed up with a clinical visit at 2 weeks and stent exchange (+ additional RFA treatment in the control arm) will be offered at 8-12 weeks interval until disease progression, clinical deterioration precluding ERCP or death.

The main study objectives are:

* To assess the technical feasibility of implementing the proposed therapeutic protocol involving a combined endoscopic-radiologic approach to drainage and ablation
* To evaluate the efficacy of radiofrequency ablation in local disease control
* To evaluate whether complete drainage and radiofrequency ablation have a cumulative benefit in patients with inoperable perihilar cholangiocarcinoma
* To evaluate the safety of our proposed therapeutic protocol combining interventional endoscopy with radiology

Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma

A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma

Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP

To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up

To evaluate the safety profile of the procedure by assessing the rate of procedure-related adverse events according to the ASGE lexicon (cholangitis, bleeding, perforation, pancreatitis) after endoscopic treatment

To assess patient survival rates at 12 months follow-up

To evaluate the expression of programmed death (PD)-1 / PD- ligand 1 markers on biopsy samples of tumor tissue obtained at the index and follow-up ERCP procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma	NCT05563870	Perihilar Chola...	Endoluminal rad... Endoscopic bili...	18 Years -	Clinical Hospital Colentina
Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma	NCT05563870	Perihilar Chola...	Endoluminal rad... Endoscopic bili...	18 Years -	Clinical Hospital Colentina

Spots Global Cancer Trial Database for endoscopic biliary stenting