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

NCT01943253 | Completed DMC

• 1 other identifier: Hybrid ESD
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Stomach Neoplasms

Keywords

Early gastric cancer,; endoscopic submucosal dissection (ESD); water-jet assisted ESD

Outcome Measures

Primary Outcomes (1)

• Procedure time

  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.

  during procedure

Secondary Outcomes (5)

• en bloc resection rate

  in procedure

• histological R0 rate

  7 days after procedure

• Histologically incomplete resection

  7 days after procedure

• procedure related morbidity and mortality and complication rate

  30 days after procedure

• complication rate

  30 days after procedure

Study Arms (2)

Conventional ESD

ACTIVE COMPARATOR

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

Device: Conventional ESD

Hybridknife ESD

ACTIVE COMPARATOR

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)

Device: Hybridknife ESD

Interventions

Conventional ESD DEVICE

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

Conventional ESD

Hybridknife ESD DEVICE

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)

Also known as: Water-jet assisted HybridKnife® ESD

Hybridknife ESD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (≥ 18 years) with confirmed diagnosis of gastric adenoma or early gastric adenocarcinoma
• differentiated mucosal adenocarinoma without ulcer findings ≤ 60 mm in diameter.
• Lesions with ulceration ≤ 30 mm in diameter.
• undifferentiated type of mucosal cancer is ≤ 20 mm.
• The patient has given written informed consent.

You may not qualify if:

• pregnancy
• coagulopathy (INR\>2.0, platelets \< 70/nl)
• evidence of local or distant metastases according to endoscopic ultrasound (EUS) and/or CT scan, EUS (7.5 MHz probe) findings of tumor infiltration into deep layers of the submucosa or muscularis propria. -Patients unfit for deep sedation by use of propofol

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Evangelisches Krankenhaus Düsseldorf: collaborator

Study Sites (1)

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Horst Neuhaus

  Evangelisches Krankenhaus Düsseldorf

  STUDY DIRECTOR

• Pinghong Zhou

  Endoscopy Center, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 16, 2013
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

DE (1)