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By combining injection and dissection capability together, O-type Hybrid knife could possibly shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative to surgery for localized early upper gastrointestinal neoplasms recently. However, the procedure remains to be technically challenging and time consuming. Many modified methods or newly developed devices were developed to simplify the procedure. A new insulated tip dissecting knife (O-type Hybrid knife) has been recently developed with both injection and lateral cutting capability. The aim of this study was to investigate whether ESD procedure could be shortened with this new device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid knife | Experimental | O-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 Comparator | IT knife is used the whole ESD process except for minimum use of dual knife in border marking and initial mucosal cutting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid knife | Device | Use Hybrid knife in ESD procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time for ESD | The time to finish the whole ESD procedure. | up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Submucosal dissection time | The time for submucosal dissection of ESD | up to 1 day |
| Perforation rate | The perforation rate of ESD during and after procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu | Xijing Hospital of Digestive Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19343433 | Background | 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. | |
| 21316668 | Background | Fukami 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| IT knife |
| Device |
Use IT knife in ESD procedure. |
|
| up to 7 day |
| Bleeding Rate | The bleeding rate of ESD during and after procedure. | up to 7 days |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |