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Randomized controlled trial on the effect of neoveil patch on anastomosis in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer

Randomized controlled trial on the effect of neoveil patch on anastomosis in patients with esophagectomy and subcutaneous reconstruction for esophageal cancer - neoveil trial in esophageal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041516
Enrollment
60
Registered
2020-08-22
Start date
2020-07-06
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

esophageal cancer

Interventions

After performing the anastomosis at the time of surgery, use a neo-veil sheet to wrap it around the anastomosis and reinforce it. Do not use Neovale

Sponsors

Osaka International Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A case of subtotal esophagectomy + subcutaneous reconstruction for histologically confirmed primary esophageal cancer. It does not consider the reconstruction organ or whether it is one-stage reconstruction or two-stage reconstruction. 1. The age at the time of registration is 20 to 85 years old. 2. Progress cT1b-T4b N does not matter M0 does not matter 3. Cases where written consent was obtained.

Exclusion criteria

Exclusion criteria: 1. Cases other than subtotal esophagectomy (eg, lower esophagectomy, cervical esophagectomy, total pharyngeolaryngeal esophagectomy, etc.) 2. Cases with a history of allergy to Neovale sheet In addition, it is judged that registration for this test is inappropriate.

Design outcomes

Primary

MeasureTime frame
Incidence of anastomotic leakage (Clavin-Dindo Grade 1 or higher) in the esophagus-stomach/jejunum/ileum/colon anastomosis

Secondary

MeasureTime frame
Incidence of anastomotic leakage (Clavin-Dindo Grade 3 or higher) in the esophagus-stomach/jejunum/ileum/colon anastomosis, incidence of anastomotic leakage in all anastomoses (Clavin-Dindo Grade 1 or higher), reoperation rate for suture failure, SSI (Surgical) Site infection) Incidence rate, period until the start of postoperative oral intake, number of postoperative hospital stays

Countries

Japan

Contacts

Public ContactKeijiro Sugimura

Osaka International Cancer Institute Department of gastroenterological surgery

sugimura-ke@mc.pref.osaka.jp06-6945-1181

Outcome results

None listed

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