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Endoscopic hand-suturing for defects closure and preventing bleeding and perforation after gastrointestinal endoscopic submucosal dissection, a prospective study

Endoscopic hand-suturing for defects closure and preventing bleeding and perforation after gastrointestinal endoscopic submucosal dissection, a prospective study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073589
Enrollment
Unknown
Registered
2023-07-14
Start date
2022-12-05
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Gastrointestinal Tumors

Interventions

Group interventon:The gastointestinal defects after Endoscopic submucosal dissection (ESD) will be closed using endoscopic hand suturing (EHS) technique

Sponsors

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Endoscopic evaluation of feasible endoscopic submucosal dissection (ESD) for gastrointestinal lesions; (2) The estimated length of the mucosal defect is 20-50mm; (3) 18 years = age = 70 years; (4) The ECOG score is 0-1 points.

Exclusion criteria

Exclusion criteria: (1) Lesions with lymph node metastasis; (2) Patients with poor general condition and inability to tolerate endoscopic surgery; (3) Patients with coagulation dysfunction (platelet count 2) or taking antithrombotic agents, before their coagulation function is corrected; (4) Patients who refuse or are not suitable for surgery; (5) Patients with previous abdominal or pelvic radiation therapy; (6) The 'lifting sign' is negative.

Design outcomes

Primary

MeasureTime frame
Complete closure rate of postoperative wounds;Delayed postoperative bleeding rate;Continuous closure rate of postoperative wounds;

Secondary

MeasureTime frame
Bleeding rate during EHS;Perforation rate during EHS;EHS time;Postoperative delayed perforation rate;Incidence of other postoperative adverse events;

Countries

China

Contacts

Public ContactGuiqi Wang

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

wangguiq@126.com+86 136 7122 9223

Outcome results

None listed

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