Clinical trial · Interventional

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

NCT07655674CI-TRIAL-00115163not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Gastric Submucosal Tumors	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Non-robotic conventional endoscopy	Device	—	UNRESOLVED
Robot system	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
RG（Robot group）
description
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.
interventionNames
1. Device: Robot system
type
ACTIVE_COMPARATOR
label
TG（Traditional Group）
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.