Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Non-robotic conventional endoscopy

    Device

    Conventional endoscopy without Robot

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: RG(Robot group)Experimental treatment 1 intervention
Group B: TG(Traditional Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serosa integrity rate

En bloc resection rate with serosa preserved

Time frame
perioperative

Secondary outcomes

1

Duration of the surgical procedure

Total duration of the surgical procedure

Time frame
Intraoperative
2

Dissection time

Dissection time of tumor

Time frame
perioperative
3

Intraoperative blood loss

Intraoperative blood loss during surgury

Time frame
perioperative
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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