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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-LCYJ-MS-12 | Other Grant/Funding Number | the Affiliated Drum Tower Hospital of Nanjing University Medical School |
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The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.
A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESD | Active Comparator | The traditional ESD treatment method is adopted, which includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife, hemostasis and cliping of the wound. Traction is allowed during the operation. |
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| mDS-EMR | Experimental | Modified double snare assisted EMR was used for treatment. Put the first snare for resecting outside the endoscope body. Then put the second snare at the base through the channel to tighten the lesion. Finally, place the first snare below the second one to tighten the lesion and perform electrically-assisted removal. Then, metal clips will be used to close the wound. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified double snare assisted endoscopic mucosal resection | Procedure | A polypectomy snare (resection snare) was placed outside of the endoscope. After approaching the lesion, a second polypectomy snare (capture snare) was inserted through the biopsy channel of the endoscope to grasp and lift the lesion. The snare preloaded outside of the endoscope was released, passed through the capture snare and positioned below the capture snare to grasp the base of the lesion. Once the lesion was securely grasped, it was resected by resection snare to achieve en bloc resection. The wounds were closed by clips. |
| Measure | Description | Time Frame |
|---|---|---|
| complete resection | Rate of complete en bloc resection with microscopically negative margins. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection | Rate of complete resection as a single piece | Day 30 |
| operation success rate | Technical success was defined as the completion of procedure without abortion or conversion to other procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed perforation | Postoperative abdominal pain, along with pelvic infection. Free gas in the pelvic cavity can be observed by imaging examination. | 30 days after the operation |
| Delayed bleeding | Hemorrhage occurs withing 30 days after the procedure that requires endoscopic, radiological, or surgical intervention, or a blood transfusion may be required. |
Inclusion Criteria:
Exclusion Criteria:
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|
| endoscopic submucosal dissection | Procedure | The procedure includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife (such as Dual knife, Golden knife or Kunpeng knife, etc.) , hemostasis and sealing of the wound. Traction is allowed during the operation. |
|
| Periprocedural |
| operation time | Operation time of ESD refers to the period from marking to completely removing the lesion, including submucosal injection, circumferential incision, submucosal dissection, additional submucosal injection and hemostasis during the operation and closure of the wound. Operation time of mDS-EMR refers to the period from the placing of the external snare to completely removing the lesion, hemostasis and closure of the wound. | Periprocedural |
| Postoperative hospital stay | Period from the day of operation to discharge | through study completion, an average of 30 days |
| operation-related expenses | Consumables cost of mDS-EMR and ESD | through study completion, an average of 30 days |
| Average hospitalization expenses | All the expenses during the hospitalization period | through study completion, an average of 30 days |
| 30 days after the operation |
| Intraoperative bleeding | arterial bleeding or active oozing for more than 30 seconds during the operation, which required endoscopic, radiological, or surgical intervention. | Intraoperative |
| Intraoperative perforation | Damage of muscular layer of rectal wall and a hole to extracavitary tissue can be observed by endoscopy. | Intraoperative |
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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