An interventional study of Robot system and Non-robotic conventional endoscopy in Gastric Submucosal Tumors, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
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.
The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Robot system
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.
Device: Non-robotic conventional endoscopy
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.
Conventional endoscopy without Robot
Serosa integrity rate
En bloc resection rate with serosa preserved
Time frame: perioperative
Duration of the surgical procedure
Total duration of the surgical procedure
Time frame: Intraoperative
Dissection time
Dissection time of tumor
Time frame: perioperative
Intraoperative blood loss
Intraoperative blood loss during surgury
Time frame: 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.
Time frame: 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.
Time frame: Within 30 days after surgery
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University