Clinical trial NCT05563870: Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma
Official title: A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perihilar Cholangiocarcinoma
Keywords: perihilar cholangiocarcinoma
ERCP
Radiofrequency ablation
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
Collaborators: name: Carol Davila University of Medicine and Pharmacy
name: Universitatea din Bucuresti
First posted: 2022-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* perihilar cholangiocarcinoma
* locally advanced disease (unresectable)
* M1 (limted to 1 site)

Exclusion Criteria:

* refusal to sogn the ICF
* poor performance status (ECOG \>2)
* surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions)
* significant comorbidities
* ASA score \>3
* life expectancy \<3 months

Primary outcomes:
measure: Technical success of ERCP procedure
timeFrame: 2 months
measure: Tumor response
timeFrame: 6 months
Secondary outcomes:
measure: Rate of procedure-related adverse events
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Tumor microenvironment alterations
timeFrame: 2 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Gastroenterology Department, Colentina Hospital
Study officials:
References: