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A strategy combining endoscopic hand-suturing with clips for rectal defects after endoscopic submucosal dissection, a prospective study

A strategy combining endoscopic hand-suturing with clips for rectal defects after endoscopic submucosal dissection, a prospective study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074220
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Rectal mucosal lesions and submucosal tumors expected to be resectable under endoscopy

Interventions

Group interventon:Close the rectal defects after ESD with or without myectomy using the strategy combining EHS with clips (EHS-Clips)

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 80 Years

Inclusion criteria

Inclusion criteria: 1.Endoscopic evaluation of feasible endoscopic submucosal dissection (ESD) with or without myectomy for rectal lesions. 2. The estimated size of the specimen is <= 50mm. 3.18 years <= age <= 80 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. 7. Some researchers believe that patients with other clinical and laboratory conditions should not participate in this trial.

Design outcomes

Primary

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

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