Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

NCT ID: NCT01378507

Last Updated: 2011-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-04-30

Brief Summary

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Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.

Detailed Description

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Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.

Conditions

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Digestive System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Submucosal Dissection

Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection

Group Type EXPERIMENTAL

endoscopic submucosal dissection

Intervention Type BEHAVIORAL

ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.

Interventions

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endoscopic submucosal dissection

ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.

Intervention Type BEHAVIORAL

Other Intervention Names

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Endoscopic Submucosal Dissection(ESD)

Eligibility Criteria

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Inclusion Criteria

* Submucosal tumor
* Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria

* Endoscopic ultrasound (EUS) or CT signs of metastasis
* Insufficient access to tumor
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastroenterology and Hepatology

Principal Investigators

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Zhong-Sheng Lu, M.D.

Role: STUDY_CHAIR

Chinese PLA General Hospital

Yun-Sheng Yang, M.D.

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Jin Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhong-Sheng Lu, M.D.

Role: CONTACT

86-10-66937467

Facility Contacts

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Jin Huang, M.D.

Role: primary

References

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Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.

Reference Type DERIVED
PMID: 26078575 (View on PubMed)

Other Identifiers

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20110526004

Identifier Type: -

Identifier Source: org_study_id

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