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Phase II trial of laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer

Phase II trial of laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery for elderly patients with early gastric cancer - Phase II trial of LECS and SNNS for elderly patients with early gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031003
Enrollment
20
Registered
2018-02-01
Start date
2018-03-01
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

gastric cancer

Interventions

Hybrid endoscopic and laparoscopic partial gastrectomy for the scar of endoscopic treatment Closing the site of gastrectomy by laparoscopic hand-sewn saturation. Sentinel lymph nodes navigation sur

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Gastric cancer requiring additional resection after ESD (All non-applied lesions, non-curative resection with absolute adaptive lesion or adaptive enlarged lesion) 2)Performance status 0 and 1 3)Over 75 years old patient 4)No history of preoperative chemotherapy for gastric cancer 5)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 6)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 laparoscopic and endoscopic cooperative surgery and sentinel lymph nodes navigation surgery

Secondary

MeasureTime frame
Surgical process (operative time, intraoperative bleeding, rates of laparotomy transition), postoperative course (oral intake, length of safety), rates of late complications (from discharge to 3 years after surgery), postoperative quality of life (QOL), overall survival (OS), disease specific survival (DSS), disease free survival (DFS)

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