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The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection

The safety and efficacy of the endoscopic tissue shielding method with polyglycolic acid sheets for wounds after endoscopic submucosal dissection - study on 'Beri-Neo' method after ESD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011058
Enrollment
120
Registered
2013-07-01
Start date
2013-07-01
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

gastrointestinal neoplasms to be resected by endoscopic submucosal dissection (ESD)

Interventions

Covering mucosal defects made after ESD with Neoveil and Beriplast

Sponsors

the Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients who will undergo ESD at our hospital and have given written informed consent to this study. And those who have a risk of developing complications: (1) ESD for large neoplasm is scheduled; (2) heparinization during cessation of antithrombotic drugs is applied; and so on.

Exclusion criteria

Exclusion criteria: 1. Those who fall under the category of contraindication of Neoveil or Beriplast. Neoveil: those who have systematic complications Beriplast: 1) those who have a history of anaphylaxis to components of Beriplast or drugs made of bovine lung, such as aprotinin 2) those who are treated with procoagulants (hemocoagulase made from snake venom), antifibrolytic agents, and aprotinin 2. Those who are considered to be inappropriate for this study by doctors

Design outcomes

Primary

MeasureTime frame
The rate of complications after ESD in conjunction with the covering method with Neoveil and Beriplast.

Secondary

MeasureTime frame
procedure time / success rate of covering / complications associated with the procedure / body temperature, the number of white blood cell, the value of C-reactive protein, and the presence of abdominal pain the next day after ESD

Countries

Japan

Contacts

Public ContactYosuke Tsuji

Graduate School of Medicine, University of Tokyo Department of Gastroenterology

ytsuji-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

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