Endoscopic Therapy of Malignant Bile Duct Strictures

Status Terminated

Clinical Trial Summary

Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA catheter is in patient with malignant bile duct stenosis.

Clinical Trial Description

As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01543607
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Terminated
Phase	N/A
Start date	February 2012
Completion date	February 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Withdrawn	`NCT03110510` - FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study	Phase 2
Completed	`NCT05116891` - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT00380588` - Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer	Phase 2
Terminated	`NCT00090025` - XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors	Phase 3
Terminated	`NCT04066491` - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC	Phase 2/Phase 3
Recruiting	`NCT05998447` - GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer	Phase 2
Recruiting	`NCT03718897` - Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
Recruiting	`NCT05056116` - A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer	N/A
Recruiting	`NCT04692051` - A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer	Phase 2
Terminated	`NCT04057365` - Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)	Phase 2
Recruiting	`NCT04907643` - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes	N/A
Completed	`NCT02829918` - Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers	Phase 2
Recruiting	`NCT04584996` - CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers
Completed	`NCT02579616` - Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy	Phase 2
Recruiting	`NCT05052099` - Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer	Phase 1/Phase 2
Recruiting	`NCT01494363` - Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer	Phase 2
Completed	`NCT00753675` - Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer	Phase 2
Terminated	`NCT00630890` - Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor)	Phase 1
Recruiting	`NCT04445532` - Hepatobiliary Tumors Tissue Samples Acquisition