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A pilot study of endoscopic hand-suturing for mucosal defects after colorectal endoscopic submucosal dissection

A pilot study of endoscopic hand-suturing for mucosal defects after colorectal endoscopic submucosal dissection - NCCH-1717

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031512
Enrollment
11
Registered
2018-04-01
Start date
2018-04-01
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 neoplasms

Interventions

endoscopic hand-suturing (EHS) for mucosal defects immediately after colorectal endoscopic submucosal dissection

Sponsors

Endoscopy Division, National Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) colorectal adenoma or adenocarcinoma 2-5cm in size scheduled for ESD 2) age20 years old or more 3) PS 0-1 4) obtained written informed consent

Exclusion criteria

Exclusion criteria: 1) high risk of post-ESD bleeding a) Plt less than 50000/mm3 or PT-INR 2 or more b) Liver chirrosis Child Pugh score B-C c) chronic kidney disease needed hemodyalysis 2) unable to discontinue antithrombotic drug according to Japanese guidelines 3) prior abdominal or pelvic surgery 4) prior radiotherapy for abdomen or pelvis 5) thought ineligible by attending endoscopist 4)

Design outcomes

Primary

MeasureTime frame
successful closure rate

Secondary

MeasureTime frame
1. Sustained closure rate post 3-4 days after ESD (only rectum and sigmoid colon) 2. Post-ESD bleeding rate 3. Perforation rate 4. other complication rate 5. procedure time for closure

Countries

Japan

Contacts

Public ContactSeiichiro Abe

National Cancer Center Hospital Endoscopy Division

seabe@ncc.go.jp03-3542-2511

Outcome results

None listed

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