Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor

Evaluation of safety and efficacy of laparoscopic and endoscopic cooperative surgery (LECS) for duodenal tumor - Evaluation of safety and efficacy of LECS for duodenal tumor

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019410

Enrollment

Registered

2015-11-20

Start date

2015-11-20

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

duodenal adenoma, eraly duodenal cancer, duodenal GIST, duodenal carcinoid

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Preoperative diagnosis is confirmed as a duodenal adenoma, early duodenal cancer, duodenal GIST and duodenal carcinoid. 2. Tumors located from bulbs to lower portion of duodenum 3. Age of more than 20 years old at 4. Performance status 0, 1 and 2 5. Fulfill all below criterion Hb =>9 g/dl Plt=>100,000/mm3 AST or ALT <=100 lU/l Serum creatinine<=2.0 mg/dl PT-INR% =>80% 6. Patients who could be followed during 56 days 7. Patients who agree the content of this study

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Patients who could not agree the content of this study. 2. Residual tumor following endoscopic resection 3. Totally of sub circumferential tumor 4. Tumors located in Ampulla of Vater 5. Tumors which the surface is near the pancreas 6. Post radiation therapy 7. Severe abdominal adhesion 8. Patients who are pregnant 9. Patients who have a psychiatric disorder 10. Patients who have active infectious or fungal disease 11. Severe hypertension 12. Severe respiratory disease 13. Patients that researchers admit inadequate for candidates

Design outcomes

Primary

Measure	Time frame
Evaluation of postoperative complication rates in LECS, in comparison with previous reported complication rates following simple endoscopic resection in duodenal tumor	—

Secondary

Measure	Time frame
Evaluation of pancereatoduodenectomy (PD) rates due to postoperative complications following LECS, in comparison with previous reported PD rates due to complications following simple endoscopic resection in duodenal tumor	—

Countries

Japan

Contacts

Public ContactShuhei Komatsu

Kyoto Prefectural University of Medicine Division of Digestive Surgery, Department of Surgery

skomatsu@koto.kpu-m.ac.jp(+81)75-251-5527

Outcome results