Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study

N/ANot Yet RecruitingNCT07655674

The First Affiliated Hospital of Soochow University110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Gastric Submucosal Tumors

Interventions

Robot systemDEVICE

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.

Non-robotic conventional endoscopyDEVICE

Conventional endoscopy without Robot

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serosa integrity rate

En bloc resection rate with serosa preserved

Time frame: perioperative

Secondary Outcomes

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

Central Contacts

Chenhuan Tan

CONTACT

+86 18860928860 tanchenhuan2013@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.