Comparison of O-type Hybrid Knife and IT Knife in ESD
1 other identifier
interventional
78
1 country
1
Brief Summary
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Typical duration 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
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 28, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 26, 2015
January 1, 2015
1.8 years
December 28, 2012
January 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedure time for ESD
The time to finish the whole ESD procedure.
up to 1 day
Secondary Outcomes (3)
Submucosal dissection time
up to 1 day
Perforation rate
up to 7 day
Bleeding Rate
up to 7 days
Study Arms (2)
Hybrid knife
EXPERIMENTALO-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
IT knife
ACTIVE COMPARATORIT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
Interventions
Eligibility Criteria
You may qualify if:
- Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications
- The patients who agreed informed consent
You may not qualify if:
- Recent drug history of anticoagulant or antiplatelet agent within 7 days
- Recurrent gastric or esophageal adenoma or early cancer
- Pregnant or breast feeding patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
Related Publications (2)
Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.
PMID: 19343433BACKGROUNDFukami N, Ryu CB, Said S, Weber Z, Chen YK. Prospective, randomized study of conventional versus HybridKnife endoscopic submucosal dissection methods for the esophagus: an animal study. Gastrointest Endosc. 2011 Jun;73(6):1246-53. doi: 10.1016/j.gie.2010.12.004. Epub 2011 Feb 12.
PMID: 21316668BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhiguo Liu
Xijing Hospital of Digestive Diseases
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 28, 2012
First Posted
January 3, 2013
Study Start
December 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
January 26, 2015
Record last verified: 2015-01