Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01378507

Enrollment

500

Registered

2011-06-22

Start date

2009-01-31

Completion date

2013-04-30

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Diseases

Keywords

endoscopic submucosal dissection, gastrointestinal neoplasm

Brief summary

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

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.

Interventions

BEHAVIORALendoscopic 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The lesion result before ESD	within 7 days before ESD	Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result after ESD	whithin 7 days after ESD	Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.

Secondary

Measure	Time frame	Description
The safety of ESD procedure	3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD	including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Countries

China

Contacts

Primary ContactZhong-Sheng Lu, M.D.

lzs936150@sohu.com86-10-66937467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026