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Efficacy and safety of gastrointestinal endoscopic surgical instrument control system (FASTER system)-assisted endoscopic submucosal dissection for rectal submucosal tumors: a prospective, single-blind, single-center, pilot randomized controlled trial

Efficacy and safety of gastrointestinal endoscopic surgical instrument control system (FASTER system)-assisted endoscopic submucosal dissection for rectal submucosal tumors: a prospective, single-blind, single-center, pilot randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122523
Enrollment
Unknown
Registered
2026-04-14
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal submucosal tumors

Interventions

Experimental group:Implement FASTER system-assisted ESD
Control group:Implement standard ESD

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and <=80 years; 2. Normal body temperature before surgery; 3. Preoperative evaluation by colonoscopy, endoscopic ultrasound, CT, and MRI shows that the patient is suitable for ESD; 4. Preoperative assessment indicates the lesion is a submucosal tumor originating from the rectal muscularis propria, with a maximum diameter <5 cm; 5. No concurrent organic diseases of the stomach or colorectal region; 6. A single ESD procedure to remove a single lesion; 7. Patients and their families can understand the study protocol, are willing to participate in this study, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Age 80 years old; 2. Individuals with low immunity, or those currently undergoing immunosuppressive therapy; 3. Patients with other organic diseases of the stomach and colorectum; 4. Patients with a history of rectal surgery that may affect the postoperative outcome of this procedure; 5. Pregnant or breastfeeding women; 6. Individuals with severe emphysema, interstitial pneumonia, or ischemic heart disease who cannot tolerate anesthesia and surgery; 7. Patients with contraindications to ESD surgery; 8. Patients or their families who are unable to understand the conditions and objectives of this study.

Design outcomes

Primary

MeasureTime frame
Procedure time;

Secondary

MeasureTime frame
R0 resection rate;Resection time;Closure time;Incidence of postoperative bleeding;Incidence of intraoperative perforation;Incidence of postoperative perforation;Incidence of postoperative electrocoagulation syndrome;

Countries

China

Contacts

Public ContactZhong Yunshi

Zhongshan Hospital affiliated to Fudan University

zhong.yunshi@zs-hospital.sh.cn+86 135 6462 3481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026