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Multi-center Prospective Clinical Study for Efficacy and Safety of Laparoscopic Double-Flap Reconstruction on Anti-reflux Potential to the Esophagus after Surgery

Multi-center Prospective Clinical Study for Efficacy and Safety of Laparoscopic Double-Flap Reconstruction on Anti-reflux Potential to the Esophagus after Surgery - lD-FLAP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036191
Enrollment
40
Registered
2019-05-01
Start date
2019-05-01
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

Gastric cancer

Interventions

Laparoscopic proximal gastrectomy with lymphadenectomy followed by double-flap reconstruction

Sponsors

Okayama University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed with gastric cancer. 2) Diagnosed with T1N0 according to Japanese Classification of Gastric Carcinoma (the 15th edition). 3) Tumor is located mainly in the upper stomach and proximal gastrectomy is considered oncologically appropriate. 4) Patients who can give written informed concent.

Exclusion criteria

Exclusion criteria: 1) Pregnant women or women with a possible pregnancy. 2) Patients who are otherwise judged by the investigator as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of reflux esophagitis at 1 year after surgery

Secondary

MeasureTime frame
Incidence of anastomosis-related complications such as leakage, stricture and bleeding

Countries

Japan

Contacts

Public ContactShinji Kuroda

Okayama Unisversity Gastroenterological Surgery

shinkuro@okayama-u.ac.jp086-235-7257

Outcome results

None listed

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