Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 22, 2011
May 1, 2011
2.4 years
June 20, 2011
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The lesion result before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
within 7 days before ESD
Short-term result 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.
whithin 7 days after ESD
Secondary Outcomes (1)
The safety of ESD procedure
3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
Study Arms (1)
Endoscopic Submucosal Dissection
EXPERIMENTALSingle-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection
Interventions
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.
Eligibility Criteria
You may qualify if:
- Submucosal tumor
- Mucosal tumor (T1) in patients unsuitable for surgery
You may not qualify if:
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Insufficient access to tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (1)
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.
PMID: 26078575DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhong-Sheng Lu, M.D.
Chinese PLA General Hospital
- STUDY DIRECTOR
Yun-Sheng Yang, M.D.
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Jin Huang, M.D.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 22, 2011
Study Start
January 1, 2009
Primary Completion
June 1, 2011
Study Completion
April 1, 2013
Last Updated
June 22, 2011
Record last verified: 2011-05