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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Tongji Hospital | OTHER |
| First Affiliated Hospital of Suzhou Medical College | OTHER |
| Shanghai Zhongshan Hospital |
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To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESTD group | Experimental | Use tunnelling method during ESD operation |
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| ESD group | Other | Use traditional method during ESD operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTD | Procedure | During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The procedure time | Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of bleeding during operation | The hemorrhage observed during the operation | day 1 |
| The rate of injury to the muscular layer | The injury to the muscular layer observed during the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu | Xijing Hospital of Digestive Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35461890 | Derived | Fan X, Wu Q, Li R, Chen W, Xie H, Zhao X, Zhu S, Fan C, Li J, Liu M, Liu Z, Han Y. Clinical benefit of tunnel endoscopic submucosal dissection for esophageal squamous cancer: a multicenter, randomized controlled trial. Gastrointest Endosc. 2022 Sep;96(3):436-444. doi: 10.1016/j.gie.2022.04.016. Epub 2022 Apr 22. |
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| OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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The operator only understands the operation method required by the patient and is unaware of the observation indicators
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| ESD | Procedure | The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection. |
|
| day 1 |