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In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RG（Robot group） | Experimental | 1.Marking and mucosal incision.2.Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.3.Perform meticulous dissection along the capsule-muscular layer interface using an ESD knife, and preserve the integrity of the serosa as much as possible.4.En bloc resection and removal of the tumor.5.Verification of serosal integrity: The procedure can be completed only if air/water insufflation test shows negative results. Mucosal defects are closed by standard techniques. |
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| TG（Traditional Group） | Active Comparator | The procedures are performed by surgeons of equivalent seniority via conventional endoscopic full-thickness resection (EFTR) or modified endoscopic submucosal dissection (modified ESD). If a safe dissection plane cannot be established, full-thickness incision is conducted followed by closure using over-the-scope clip (OTSC), covered stent or suturing techniques. Leakage is assessed and managed in accordance with standard protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot system | Device | After Marking and mucosal incision，Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer. |
| Measure | Description | Time Frame |
|---|---|---|
| Serosa integrity rate | En bloc resection rate with serosa preserved | perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the surgical procedure | Total duration of the surgical procedure | Intraoperative |
| Dissection time | Dissection time of tumor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenhuan Tan | Contact | +86 18860928860 | tanchenhuan2013@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Li | The First Affiliated Hospital of Soochow University | Principal Investigator |
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The shared datasets cover all collected de-identified individual participant data related to this trial, such as demographic data, imaging findings, surgical data, complication records and pathological results. No personal identifiable information will be retained. Data will be available to qualified researchers for legitimate scientific research use.
Beginning 6 months after publication of study results and ending 2 years thereafter
Access is limited to qualified researchers for legitimate scientific research purposes. All de-identified IPD and selected supporting documents are available. Researchers need to submit a formal application, and data will be provided upon approval.
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| Non-robotic conventional endoscopy | Device | Conventional endoscopy without Robot |
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| perioperative |
| Intraoperative blood loss | Intraoperative blood loss during surgury | perioperative |
| Postoperative fever rate | Postoperative fever is defined as a body temperature ≥ 37.5 ℃ within 7 days after surgery. All febrile cases during this period are included, including non-infectious absorption fever. | Within 7 days after surgery |
| Postoperative infection | Postoperative infection is diagnosed when body temperature reaches ≥ 38.5 ℃, or temperature ≥ 38.0 ℃ persists for more than 3 consecutive days starting from postoperative day 3. Diagnosis shall be confirmed by clinical symptoms, abnormal laboratory inflammatory indicators or positive microbial culture results. Simple absorption fever is excluded. | Within 30 days after surgery |