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Prospective Observational Study on the Efficacy and Safety of Endoscopic Suturing Using Mantis for Mucosal Defects After Colorectal Endoscopic Submucosal Dissection (ESD)

Prospective Observational Study on the Utility of a Suturing Technique for Colonic ESD Post-Mucosal Defects Without Creating Submucosal Dead Space, Utilizing the Sharp-Hooked Tip Clip - SHARK TRIAL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1072230133
Enrollment
50
Registered
2024-03-28
Start date
2024-03-28
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Colorectal neoplasm Colorectal neoplasm

Interventions

Endoscopic Mucosal Resection

Sponsors

Sumida Yorinobu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with colorectal epithelial tumors of 20-50mm through endoscopic examination, undergoing ESD. (2) Preoperative diagnosis is adenoma or early cancer (cT1a). (3) Patients who are 20 years of age or older at the time of consent acquisition. (4) Patients with a Performance Status of 0, 1, or 2. (5) Patients who have received sufficient explanation about this research plan, fully understand it, and are capable of giving consent on their own.

Exclusion criteria

Exclusion criteria: (1) Cecal lesions involving the ileocecal valve or the opening of the appendix. (2) Colonic lesions involving a diverticulum. (3) Rectal lesions involving the lower rectum. (4) Patients undergoing dialysis. (5) Patients requiring continuous administration of heparin during the perioperative period. (6) Patients for whom endoscopic examination is contraindicated (patients with ileus, gastrointestinal perforation, severe respiratory diseases, and cardiovascular diseases). (7) Patients deemed inappropriate for the study by the attending physician.

Design outcomes

Primary

MeasureTime frame
Complete suture rate of the wound

Secondary

MeasureTime frame
(1) Number of suturing clips used (Mantis/Long/Normal/Short) (2) Suturing time (3) Rate of submucosal dead space (SDS) formation (4) ESD duration (5) En bloc resection (6) Complete en bloc resection (7) Curative resection (8) Operator change during wound suturing

Contacts

Public ContactTaisuke Inada

Gastroenterology

rice00field@gmail.com+81-935411831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026