Neoplasms

Digestive System Diseases

All Conditions

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction in Austria between November 2010 and December 2012.

Endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter uses bipolar electrical energy for tissue coagulation and can be applied without any special patient preparation in the context of an endoscopic retrograde cholangiopancreatography (ERCP) examination to treat malignant biliary strictures.

Endoscopic radiofrequency ablation

ERCP is used to guide the RFA-catheter under radiological control to the location of the malignant stricture.

Endoscopic retrograde cholangiopancreatography (ERCP)

Used to apply radiofrequency energy to the malignant biliary stricture (see also intervention "endoscopic radiofrequency ablation")

HabibTM EndoHPB catheter

Werner Dolak, MD

Biliary obstruction is importantly influencing quality of life and survival of patients suffering from primary or secondary bile duct malignancies. The aim of this retrospective data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures performed in Austria so far will be analyzed with regard to feasibility and safety of the technique. Therefore, the following parameters will be assessed: (among others) technical failures during the RFA procedure, complications during the RFA procedure, hospital stay, adverse events during hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results of this study should help to better understand important aspects of biliary RFA which may positively influence future applications of this method.

Introduction

Biliary obstruction is the most relevant life limiting factor in patients suffering from primary or secondary bile duct malignancies. Underlying tumors, such as extrahepatic cholangiocarcinoma (CCa) of Klatskin type, pancreatic adenocarcinoma or metastases of colorectal cancer, are often diagnosed at an advanced stage when presenting with biliary obstruction. This mostly restricts treatment strategies to palliative management. Within this setting the prevention of biliary complications like jaundice, cholangitis or cholangiosepsis is one of the therapeutic key factors to extend survival and maintain quality of life \[De Groen, Skipworth\]. Endoscopic stenting of the biliary tract is an easy and safe approach to restore biliary drainage \[Smith\]. Self-expanding metal stents are preferred to plastic stents because of the lower risk of stent occlusion \[Kaassis, Soderlund\]. In addition to stenting endoscopic therapies that directly affect the local tumor mass, have been developed within the past years. First of all, photodynamic therapy using different photosensitizers has shown promising results for the reduction of tumor size and maintenance of biliary drainage \[Ortner, Zoepf\]. However, the patient management for this treatment involving peri-interventional photosensitivity remains cumbersome.

Recently, an endoscopically applicable radiofrequency catheter for the biliary tract, the so called HabibTM EndoHBP catheter, was introduced into the market. It uses bipolar electrical energy for tissue coagulation and can be applied without any special patient preparation in the context of an endoscopic retrograde cholangiopancreatography (ERCP) examination. RFA is well known from transcutaneous applications, where it already proved to be effective as a treatment option for hepatocellular carcinoma or intrahepatic CCa \[Minami\]. The new HabibTM EndoHBP catheter was already evaluated ex vivo \[Itoi\] and showed promising results concerning safety and prevention of stent occlusion in the context of one small retrospective clinical study \[Steel\].

Primary objective

Feasibility and safety of endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter for the treatment of malignant biliary obstruction

Study Design

Retrospective analysis of prospectively gained clinical data

Primary endpoint

Technical failures during the RFA procedure

Secondary endpoints

1. Complications during the RFA procedure
2. Hospital stay
3. Adverse events during hospital stay and unil first clinical control after discharge (an expected average of 4 weeks after RFA procedure)
4. 30-day and 90-day mortality

Study Population

All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction between November 2010 and December 2012 in Austria.

Methods

Endoscopic examination report databases will be screened for "radiofrequency ablation" in the context of an "endoscopic retrograde cholangiopancreatography" to identify the mentioned study population. Examination reports, discharge letters and patient curves of the study patients will be screened to yield the following parameters:

* Demographics

  * Sex
  * Age at first RFA-intervention
* Underlying disease that led to malignant biliary obstruction

  * Type of underlying disease
  * Time from diagnosis to first RFA-intervention
  * Previous treatment attempts (chemotherapy, radiation therapy, photodynamic therapy)
* Procedure related parameters

  * Prior biliary stents (type, amount)
  * Date of RFA procedure
  * Amount of RFA-applications during the procedure (energy, time)
  * Technical failure of the RFA catheter during the RFA procedure (defined as any technical problem that hinders the satisfactory application of RFA)
  * Complications during the RFA procedure (defined as any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant by the physician, whether or not considered related to the medical device)
  * Stenting after the procedure (type, amount)
* Post-interventional parameters

  * Days of hospitalization after the RFA procedure
  * Adverse events during hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure) defined as any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant by the physician, whether or not considered related to the medical device
  * Survial status (dead/alive) at the time of the data collection
  * (Cause of death)
  * (Time between first RFA procedure and death)

Data processing will be done after pseudonymization using continuous patient identification numbers. All parameters will be assessed descriptively. For scaled parameters (e.g. age) median and range will be calculated, for nominal parameters (e.g. type of underlying disease) the proportions of sub-items will be reported. Mortality will be assessed creating a Kaplan Meyer curve. 30-day and 90-day mortality will be extrapolated from this curve. All data processing will be done with SPSS 19.0.

Risk/Benefit assessment

Due to its retrospective design this study does not inherit any risk for the study patients.

Expected impact and Outlook

The results of this study may help to better understand the feasibility and safety profile of endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter with potential effects on future applications.

Radiofrequency Ablation for Malignant Biliary Obstruction

Endoscopic Radiofrequency Ablation for Malignant Biliary Obstruction

Duration of hospitalization after the performance of RFA.

Adverse events occuring within 30 days after the RFA-procedure, defined as any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant by the physician, whether or not considered related to the medical device.

Deaths occuring within 30 and 90 days after the RFA-procedure.

The technical feasibility in this study will be specified as ratio of all technically successful RFA-applications to all examinations in which RFA-use was intended. A RFA-application will be classified as technically successful if it is possible to introduce the RFA-catheter into the biliary system, place it adequately accross the malignant stricture, apply RFA-energy and withdraw the RFA-catheter after RFA-application.

Clinically relevant complications occuring during the use of RFA, defined as any adverse change from the subject's baseline condition, which is considered to be clinically relevant by the physician, whether or not considered related to the medical device (e.g. bleeding, perforation).

Medical University of Vienna

Principal Investigator

Symptoms and General Pathology

Barrett Esophagus

Hyperplasia

Precancerous Conditions

Esophageal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Central Nervous System Depressants

Antineoplastic Agents

Vitamins

Acetic Acid

Propofol

Retinol acetate

Endoscopic surveillance and PPI treatment

HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W

Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Endoscopic surveillance

Frederic PRAT, MD, PhD

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.

Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.

Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.

120 patients are planned to be included for at least 40 patients randomized in each group.

Primary endpoint: Prevalence of LGD in each group 3 years after randomization

Secondary endpoints:

* Prevalence of LGD in each group 1 and 5 years after randomization
* Rate of complete eradication of BE at 1, 3 and 5 years after randomization
* Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
* Rate of complications in RFA group after randomization
* Cost - efficacy comparison of the 2 strategies

Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Assistance Publique - Hôpitaux de Paris

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Constriction, Pathologic

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Bile Duct Cancer

Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) would be inserted to bypass the site of narrowing (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea)

Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The radiofrequency ablation (EBRFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter with energy delivered by an RFA generator would be used to apply RFA to the entire length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. Patients would undergo 2 sessions of EBRFA 2 weeks apart. A plastic stent would be inserted in between the 2 sessions. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after the second EBRFA.

The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.

SEMS only

The radiofrequency ablation (RFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter is a bipolar RFA probe that is 8F (2.6 mm), 1.8 m long, compatible with standard (3.2-mm working channel) side-viewing endoscopes, and passes over 0.035-inch guidewires. The catheter has 2 ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5-cm length. Depending on the length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after 2 sessions of EBRFA.

EBRFA and SEMS

Malignant bile duct obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life, and decrease survival. To relieve obstructive jaundice as a result of the obstruction, endoscopic stent placement is usually required. The use self-expandable metal stents (SEMSs) have been shown to result in a longer patency times as compared with plastic stents. However, despite improvements in materials and stent design, stent obstruction still occurs in 13% to 44% of the patients. Tumor in-growth is the most common mechanism of stent obstruction.

Recently, the use of endoscopic biliary radiofrequency ablation (EBRFA) have been described in patients suffering from inoperable malignant distal common bile duct (CBD) obstruction. The procedure uses heat energy to cause local tumour tissue death, resulting in re-opening of the bile duct lumen. The procedure has the potential of reducing the rate of stent obstruction after SEMS and also prolonging survival. The safety profile appears to be comparable that of placement of SEMS alone without added complications (\<10%). The aim of the current study is to compare the efficacy of EBRFA with the addition of SEMS to SEMS alone in a randomized controlled trial.We hypothesize that the application of EBRFA can reduce recurrent biliary obstruction after SEMS.

Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures

A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.

Chinese University of Hong Kong

Honorary Assistant Professor

Gastroesophageal Reflux

Circumferential ablation with radiofrequency ablation will be performed for each segment of the BE starting from the proximal end with one ablation at 12J/cm2, followed by cleaning of mucosal slough with esophageal cap, patient extubation, cleaning of ablation device with wet gauze, and finally a second ablation at 12 J/cm2 (1 × 12J/cm2-clean-1 × 12 J/cm2). Focal ablations will be performed with three consecutive ablations at 12 J/cm2 without cleaning (simplified protocol).

Patients in the Hybrid argon plasma coagulation group will be treated with a single ablation per session with a power limitation of 60 W (pulsed mode (VIO® 300 D \& APC 2, PULSED APC®, Effect 2). No scraping with the endoscope cap and second ablation will be performed.

Endoscopic ablation technique for Barrett's epithelium

Endoscopic hybrid argon plasma coagulation

Wladyslaw Jannuszewicz, MD

Jaroslaw Regula, MD, PhD

Jaroslaw Regula, M.D., PhD

Wladyslaw Januszewicz, MD

This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.

Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.

Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus

Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)

Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure.

Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)

Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia)

Evaluated by the QLQ-OES18 questionnaire specific for esophageal symptoms, and consists of a symptom scale only. The QLQ-OES18 includes 18 questions: 6 single item subscales relating to saliva swallowing, choking, dry mouth, taste, coughing, and talking. It also includes 12 items grouped into 4 subscales: dysphagia (3 items), eating (4 items), reflux (2 items), and pain (3 items).

Intra-procedural complications, such as bleeding, perforation, post-procedural complications, e.g. chest-pain, esophageal stricture will be monitored during the hospital stay and follow-up at day 7 and day 30 after the procedure (phone call).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency Ablation for Malignant Biliary Obstruction	NCT01758341	Biliary Tract N...	Endoscopic radi... Endoscopic retr... HabibTM EndoHPB...	18 Years -	Medical University of Vienna
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia	NCT01360541	Barrett Oesopha... Low Grade Dyspl...	Endoscopic radi... Endoscopic surv...	18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures	NCT01721174	Pancreatic Canc... Cholangiocarcin...	SEMS only EBRFA and SEMS	18 Years -	Chinese University of Hong Kong
Radiofrequency Ablation for Malignant Biliary Obstruction	NCT01758341	Biliary Tract N...	Endoscopic radi... Endoscopic retr... HabibTM EndoHPB...	18 Years -	Medical University of Vienna
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus	NCT05051475	Barrett Esophag... Esophageal Aden... Reflux Disease	Endoscopic radi... Endoscopic hybr...	18 Years - 80 Years	Centre of Postgraduate Medical Education

Spots Global Cancer Trial Database for endoscopic radiofrequency ablation