Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Liver Neoplasms

Cholangitis

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.

Systemic chemotherapy and bile duct stenting without RFA.

Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Intraductal biliary radiofrequency ablation

Johann von Felden, MD

The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:

* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).

Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma

• Time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin \>5 mg/dl and/or cholangitis (fever \>38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent Endpoint Review Committee \[ERC\].)

The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects.

A high scale score represents a higher response level.

Rate of clinical events defined as per primary outcome after 6 months follow up

Universitätsklinikum Hamburg-Eppendorf

Principal Investigator

Gland and Hormone Related Diseases

Symptoms and General Pathology

Pancreatic Neoplasms

Jaundice

Jaundice, Obstructive

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Hyperbilirubinemia

Skin Manifestations

Pancreatic Cancer

Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.

At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.

Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.

Stent Dysfunction

Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Complications

shyam varadarajulu, MD

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

A manuscript will be developed following completion of the study.

Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma	NCT06175845	Cholangiocarcin... Klatskin Tumor Bile Duct Cance... Liver Cancer	Intraductal bil...	18 Years -	Universitätsklinikum Hamburg-Eppendorf
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression	NCT01675908	Obstructive Jau... Pancreatic Canc...	Stent Dysfuncti... Complications	19 Years -	AdventHealth

Spots Global Cancer Trial Database for stent dysfunction