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Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum - Phase II trial of feasibility of efficacy and safety of laparoscopy endoscopy hybrid surgery for low malignant tumor of duodenum

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021200
Enrollment
20
Registered
2016-03-01
Start date
2016-03-01
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

Duodenal adenoma, duodenal mucosal cancer, duodenal NET, duodenal SMT

Interventions

Hybrid endoscopic and laparoscopic partial duodenectomy for low malignant tumor of duodenum. Closing the site of duodenectomy by laparoscopic hand-sewn saturation.

Sponsors

Second Department of Surgery, Wakayama Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Duodenal adenoma, duodenal mucosal cancer (adenocarcinoma), duodenal NET (less than 20 mm, longer axis), duodenal SMT (less than 50 mm, longer axis) 2)Intraluminal developmental form of SMT 3)Performance status o and 1 4)Plt => 100,000/mm3 Creatinine <= 2.0 mg/dl AST <= 200 IU/L ALT <= 200 IU/L T-bil <= 2.0 mg/dl Hb => 8.0 g/dl 5)Patients who gave written informed consent before entry in this study

Exclusion criteria

Exclusion criteria: 1)Ischemic heart disease 2)Liver cirrhosis, active hepatitis 3)Interstitial pneumonia 4)Haemodialysis 5)Both malignant disorder 6)Severe abdominal adhesion 7)Doctor's decision not to register to this regimen

Design outcomes

Primary

MeasureTime frame
Postoperative one-week complication rates in laparoscopy endoscopy hybrid surgery

Secondary

MeasureTime frame
Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis).

Countries

Japan

Contacts

Public ContactToshiyasu Ojima

Wakayama Medical University Second Department of Surgery

tojima@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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