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| Name | Class |
|---|---|
| Evangelisches Krankenhaus Düsseldorf | OTHER |
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The water-jet assisted ESD technique should be shorter than the conventional ESD techniques using IT2-, Dual- and Hook-Knifes at least with the same safety and effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional ESD | Active Comparator | Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe |
|
| Hybridknife ESD | Active Comparator | Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional ESD | Device | Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany; Olympus Japan) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | The primary objective of the study is the procedure time of ESD using the conventional ESD technique in comparison to the water-jet assisted HybridKnife®-ESD technique. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| en bloc resection rate | Resection of the targeted lesion including coagulation markers in one piece. | in procedure |
| histological R0 rate | En-bloc resection and histological confirmation of horizontal and vertical free margins of neoplasia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Neuhaus | Evangelisches Krankenhaus Düsseldorf | Study Director |
| Pinghong Zhou | Endoscopy Center, Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | Germany |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Hybridknife ESD | Device | Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) |
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| 7 days after procedure |
| Histologically incomplete resection | Tumor infiltrated (R1) or undetermined (RX) margins of the resected specimen. | 7 days after procedure |
| procedure related morbidity and mortality and complication rate | procedure related morbidity and mortality | 30 days after procedure |
| complication rate | any complication occurs after procedure within 30 days, such as bleeding or perforation rates | 30 days after procedure |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |