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Bile Duct Neoplasms clinical trials

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NCT ID: NCT01755013 Recruiting - Cholangiocarcinoma Clinical Trials

Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical intervention for the sale is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. A randomized controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. In photodynamic therapy (PDT) the uniform distribution of externally applied light is desirable but often difficult to achieve. An optical fiber tip producing cylindrical or lateral light emission can facilitate the application of laser energy by direct implantation of the tip into solid tumors. However, currently used FDA approved glass diffusers used in standard of care PDT might break in the bile ducts causing injury since they are not meant to be used within bile ducts through an endoscope or choledochoscope. Hence, there is a need to evaluate and introduce more efficient and safe non-glass cylindrical optic fiber diffuser for photo dynamic therapy in the bile ducts. Recent studies have shown that the Pioneer plastic optic diffuser is safe and effective in photodynamic therapy, it can be also used via a choledochoscope. We aim to add to the clinical evidence by conducting an open label observational study trial using this fiber optic diffuser during photo dynamic therapy in the bile ducts.

NCT ID: NCT01522573 Recruiting - Pancreatic Cancer Clinical Trials

T-EUS for Gastrointestinal Disorders: A Multicenter Registry

EUSERCPReg
Start date: November 2011
Phase: N/A
Study type: Observational

The purpose of this registry is to record information and evaluate the impact of Endoscopic Ultrasound (EUS) Guided Endoscopic retrograde cholangiopancreatography (ERCP) on the management of pancreatico-biliary disorders. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS)Guided Endoscopic retrograde cholangiopancreatography (ERCP) procedures. The safety and efficacy of various EUS-Guided ERCP procedures have been assessed in a series of studies. This multi-center registry has been initiated: - To document the impact of EUS-Guided ERCP procedures on the management of pancreatico-biliary disorders including malignancies. - To assess the clinical and technical success rates of EUS-Guided ERCPs for diagnostic or therapeutic procedures. Design is retrospective and prospective registry study. Procedures that will be captured include: 1. EUS-Coils placement 2. EUS Glue injection 3. EUS-Fiducial placement 4. EUS-Neurolysis 5. EUS-Stent placement 6. EUS-alcohol injection 7. EUS-fluid collection, abscess or cavity drainage 8. EUS guided ductal drainage 9. EUS-guided Ablation 10. EUS-guided anastomosis 11. EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage

NCT ID: NCT01439698 Recruiting - Pancreatic Cancer Clinical Trials

Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry

RFA-Registry
Start date: September 2011
Phase: N/A
Study type: Observational [Patient Registry]

The objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

NCT ID: NCT01438385 Recruiting - Colorectal Cancer Clinical Trials

Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Start date: July 2011
Phase: N/A
Study type: Observational

Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.

NCT ID: NCT01317069 Recruiting - Gallbladder Cancer Clinical Trials

A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

Start date: June 2010
Phase: Phase 2
Study type: Interventional

Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.

NCT ID: NCT01016002 Recruiting - Clinical trials for Non-curative Resectable Bile Duct Carcinoma

Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Start date: January 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

NCT ID: NCT00915863 Recruiting - Clinical trials for Pancreatic Neoplasms

Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.