Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study

NCT07655674 | Not Yet Recruiting

• 1 other identifier: 2026250
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Gastric Submucosal Tumors

Keywords

gastric submucosal tumors; Robotic endoscope

Outcome Measures

Primary Outcomes (1)

• Serosa integrity rate

  En bloc resection rate with serosa preserved

  perioperative

Secondary Outcomes (5)

• Duration of the surgical procedure

  Intraoperative

• Dissection time

  perioperative

• Intraoperative blood loss

  perioperative

• Postoperative fever rate

  Within 7 days after surgery

• Postoperative infection

  Within 30 days after surgery

Study Arms (2)

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.

Device: Robot system

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.

Device: Non-robotic conventional endoscopy

Interventions

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.

RG（Robot group）

Non-robotic conventional endoscopy DEVICE

Conventional endoscopy without Robot

TG（Traditional Group）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old;
• 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);
• Tumor diameter ranging from 1.0 cm to 3.0 cm;
• No active ulcer or bleeding on the lesion surface before operation;
• American Society of Anesthesiologists (ASA) physical status class I-III;
• Voluntarily signed written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Officials

• Rui Li

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhuan Tan

CONTACT

+86 18860928860; tanchenhuan2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of study results and ending 2 years thereafter
• 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.