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Klatskin Tumor clinical trials

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NCT ID: NCT03307538 Completed - Klatskin Tumor Clinical Trials

Stereotactic Body Radiation Therapy for Unresectable Perihilar Cholangiocarcinoma

STRONG
Start date: November 6, 2017
Phase: N/A
Study type: Interventional

Rationale: For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma palliative chemotherapy is the standard treatment yielding an estimated median overall survival of 12-15.2 months. There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. However, small and most often retrospective studies combining chemotherapy with SBRT showed promising results with overall survival reaching up to 33-35 months. Based upon these observations, the investigators designed a local feasibility trial with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma in order to try to confirm the observed tolerability of adding SBRT to standard chemotherapy. The expected time to include the required patients for this pilot study will be one year. Objective: To assess feasibility of SBRT as add on treatment after standard chemotherapy. Study design: Local feasibility trial. Study population: Patients diagnosed with perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-1 M0 (AJCC 7th Edition), after completion of standard chemotherapy. Exclusion criteria are local tumor growth into either stomach, colon, duodenum, pancreas or abdominal wall. Sample size will be 6 patients. Intervention: SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT. Main study parameters/endpoints: The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity according to CTC v4.0.3. Secondary endpoints will be: - Quality of life - Local progression - Progression free survival - Overall survival - Cellular radiosensitivity.

NCT ID: NCT03132649 Recruiting - Clinical trials for Hilar Cholangiocarcinoma

Impact of Three-dimensional Visualization on Operation Strategy and Complications for Hilar Cholangiocarcinoma

Start date: March 15, 2017
Phase:
Study type: Observational

The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for hilar cholangiocarcinoma.

NCT ID: NCT03104582 Completed - Cholangitis Clinical Trials

Best Biliary Drainage Option in Advanced Klatskin Tumor

Start date: November 1, 2011
Phase: N/A
Study type: Interventional

To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

NCT ID: NCT03104569 Not yet recruiting - Cholangitis Clinical Trials

Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.

NCT ID: NCT03003065 Completed - Cholangiocarcinoma Clinical Trials

Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers

PDT
Start date: March 28, 2014
Phase: Phase 2
Study type: Interventional

In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents in patients with inoperable bile duct cancers. In addition as a preliminary study we sought to determine if the treatment can reduce tumor volume in the short term.

NCT ID: NCT02958059 Recruiting - Klatskin Tumor Clinical Trials

Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality. Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected. In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.

NCT ID: NCT02955771 Terminated - Clinical trials for Hilar Cholangiocarcinoma

Efficacy and Safety Study of PDT Using Deuteporfin for Unresectable Advanced Perihilar Cholangiocarcinoma

Start date: May 17, 2017
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, controlled, open-label, phase IIa clinical study.The study will observe the efficacy and safety of Deuteporfin photodynamic therapy in addition to stenting compared to stenting alone in patients with unresectable advanced Perihilar Cholangiocarcinoma.

NCT ID: NCT02856568 Withdrawn - Clinical trials for Unresectable Extrahepatic Bile Duct Carcinoma

Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma

Start date: May 1, 2017
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of ricolinostat when given together with gemcitabine hydrochloride and cisplatin in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ricolinostat together with gemcitabine hydrochloride and cisplatin may work better in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places.

NCT ID: NCT02801500 Recruiting - Clinical trials for Hilar Cholangiocarcinoma

Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

CTREG
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.

NCT ID: NCT02374489 Terminated - Cholangiocarcinoma Clinical Trials

A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma

Start date: March 2015
Phase: Phase 2
Study type: Interventional

Primary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The progression-free survival ,The disease control rate ,The overall survival ,The toxicity profiles , The correlation between clinical outcomes and the potential predictive biomarker for tumor response