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An Exploratory Study on Endoscopic Hand-Suturing for Closure of Gastrointestinal Defects Involving Resection of the Muscularis Propria

An Exploratory Study on Endoscopic Hand-Suturing for Closure of Gastrointestinal Defects Involving Resection of the Muscularis Propria

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102894
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Gastric wall defects resulting from endoscopic treatment for gastric lesions—including early-stage cancer, precancerous lesions, and submucosal tumors—with partial or complete resection of the muscularis propria

Interventions

Congtrol group:Metal clip related closure
Test group:Endoscopic Hand-Suturing

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Gastric lesions that are deemed endoscopically resectable upon evaluation; 2. Underwent endoscopic surgery with partial or complete resection of the muscularis propria; 3. Age between 18 and 75 years (inclusive); 4. Preoperative ECOG performance status score of 0–1.

Exclusion criteria

Exclusion criteria: 1. Lesions with confirmed lymph node metastasis; 2. Poor general condition or inability to tolerate endoscopic surgery; 3. Patients with coagulation disorders (platelet count 2) or on anticoagulant therapy prior to correction of coagulation status; 4. Patients who have received radiotherapy to the surgical site; 5. Lesions that cannot be completely resected endoscopically; 6. Defects adjacent to or involving the cardia or pylorus; 7. Patients who refuse surgery or decline participation in the clinical trial; 8. Any other clinical conditions deemed inappropriate for trial participation by the investigators.

Design outcomes

Primary

MeasureTime frame
Sustained closure rate of postoperative defects;

Secondary

MeasureTime frame
Postoperative delayed bleeding;Postoperative delayed perforation;Success rate of postoperative defect closure;Other postoperative adverse events;Suturing time;

Countries

China

Contacts

Public ContactShibo Song

Peking University First Hospital

songshibo1994@163.com+86 16601109336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026