Clinical trial · Interventional
Comparison of O-type Hybrid Knife and IT Knife in ESD
Comparison of O-type Hybrid Knife and IT Knife in Endoscopic Submucosal Dissection for Upper Gastrointestinal Neoplasms: a Prospective Randomized Controlled Trial
NCT01760070CI-TRIAL-00016689completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Dysplasia | Esophageal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
| Stomach Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid knife | Device | — | UNRESOLVED |
| IT knife | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hybrid knife
- description
- O-type Hybrid knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
- interventionNames
- Device: Hybrid knife
- type
- ACTIVE_COMPARATOR
- label
- IT knife
- description
- IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting.
- interventionNames
- Device: IT knife
Primary outcomes (1)
- measure
- Procedure time for ESD
- timeFrame
- up to 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Gastric or esophageal adenoma or early cancer which is eligible for conventional ESD indications * The patients who agreed informed consent Exclusion Criteria: * Recent drug history of anticoagulant or antiplatelet agent within 7 days * Recurrent gastric or esophageal adenoma or early cancer * Pregnant or breast feeding patients.
References
Publications (2)
- BACKGROUNDLingenfelder 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 19343433
- BACKGROUNDFukami 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 21316668