Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Conventional ESD arm indicates the group in which conventional ESD method is applied for the dissection of colorectal neoplasm.

Optimized ESD with snaring arm indicates the group in which optimized ESD with snaring method is applied for the dissection of colorectal neoplasm.

Optimized ESD with snaring

Conventional ESD

Jeong-Sik Byeon, MD

Jeong-Sik Byoen, MD

This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.

Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current.

The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.

Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

Comparison of Coventional Endoscopic Submucosal Dissection and Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

Asan Medical Center

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe

Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)

Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)

Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany; Olympus Japan) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe

Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)

Hybridknife ESD

Horst Neuhaus

Pinghong Zhou

1. Introduction The aim of the study is to evaluate the efficacy and safety of ESD by use of a new water-jet assisted ESD system using the HybridKnife® in patients with early gastric neoplastic lesions in comparison to the conventional ESD established in Japan. The water-assisted ESD technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions as well as coagulation of bleeding can be performed with the same device without need for changing the instrument. These options should accelerate the procedure and may increase its safety and efficacy.
2. Hypothesis The water-jet assisted ESD technique using the HybridKnife® bears the advantage of less instrument changes due to the combination of high-frequency cutting and water-jet application in one single instrument. This should lead to a simplified ESD procedure, shorter learn-ing curve and especially to a shorter procedure time.

The water-jet assisted ESD technique should be shorter than the conventional ESD techniques using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.

Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer

Water-jet Assisted Endoscopic Submucosal Dissection (ESD) in Comparison to Conventional ESD Technique for Treatment of Early Gastric Cancer

The primary objective of the study is the procedure time of ESD using the conventional ESD technique in comparison to the water-jet assisted HybridKnife®-ESD technique.

Resection of the targeted lesion including coagulation markers in one piece.

En-bloc resection and histological confirmation of horizontal and vertical free margins of neoplasia.

Tumor infiltrated (R1) or undetermined (RX) margins of the resected specimen.

procedure related morbidity and mortality

any complication occurs after procedure within 30 days, such as bleeding or perforation rates

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm	NCT01944540	Colorectal Neop...	Optimized ESD w... Conventional ES...	18 Years -	Asan Medical Center
Water-jet Assisted ESD vs Conventional ESD Technique for Treating Early Gastric Cancer	NCT01943253	Stomach Neoplas...	Conventional ES... Hybridknife ESD	18 Years -	Shanghai Zhongshan Hospital
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm	NCT01944540	Colorectal Neop...	Optimized ESD w... Conventional ES...	18 Years -	Asan Medical Center

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