Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study

Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Submucosal Tumors
• Intervention / Treatment: Device: Robot system; Device: Non-robotic conventional endoscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chenhuan Tan; Phone Number: +86 18860928860; Email: tanchenhuan2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
3. Tumor diameter ranging from 1.0 cm to 3.0 cm;
4. No active ulcer or bleeding on the lesion surface before operation;
5. American Society of Anesthesiologists (ASA) physical status class I-III;
6. Voluntarily signed written informed consent.

Exclusion Criteria:

1. Tumor adhesion to serosa with unclear interface shown on EUS;
2. High-risk GIST or distant metastasis indicated by imaging or endoscopy;
3. History of gastric surgery or radiotherapy;
4. High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
5. Pregnant or breastfeeding women;
6. Failure to cooperate with follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RG（Robot group）; 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; 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.
Active Comparator: TG（Traditional Group）; 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; Conventional endoscopy without Robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serosa integrity rate	En bloc resection rate with serosa preserved	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the surgical procedure	Total duration of the surgical procedure	Intraoperative
Dissection time	Dissection time of tumor	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Rui Li, The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: gastric submucosal tumors; Robotic endoscope
• Other Study ID Numbers: 2026250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication of study results and ending 2 years thereafter
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No