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Stomach NeoplasmsNCT01943253

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

A study testing Conventional ESD and Hybridknife ESD in people with Stomach Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Conventional ESD and Hybridknife ESD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteGermany
Study dates
May 2011to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • pregnancy
  • coagulopathy (INR>2.0, platelets < 70/nl)
  • mucosal lesions which did not meet the inclusion criteria
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf

Other trials in Germany

About this study

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

  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.

Being tested
Conventional ESD, Hybridknife ESD
Keywords
Early gastric cancer,, endoscopic submucosal dissection (ESD), water-jet assisted ESD
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional ESDDevice

    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

  • Hybridknife ESDDevice

    Also called Water-jet assisted HybridKnife® ESD

    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)

Study groups in NCT01943253
Study groupRoleWhat they receive
Conventional ESDActive comparatorConventional 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
Receives: Device: Conventional ESD
Hybridknife ESDActive comparatorGroup 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)
Receives: Device: Hybridknife ESD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during procedure

Secondary outcomes (5)

  1. en bloc resection rate

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

    Measured: in procedure

  2. histological R0 rate

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

    Measured: 7 days after procedure

  3. Histologically incomplete resection

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

    Measured: 7 days after procedure

  4. procedure related morbidity and mortality and complication rate

    procedure related morbidity and mortality

    Measured: 30 days after procedure

  5. complication rate

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

    Measured: 30 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2013 (estimated)
  2. Study startMay 2011
  3. Primary completionJul 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01943253
Sponsor's protocol ID
Hybrid ESD
Status last verified
Sep 2013
First submitted
4 Sep 2013
Last updated
16 Sep 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Conventional ESD and Hybridknife ESD in people with Stomach Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure time (time frame: during procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01943253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013; AzTrials last refreshed its copy on 1 Nov 2026.

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