Clinical trial · Interventional
Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic sentinel lymph node biopsy
- description
- This is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable.
- interventionNames
- Procedure: Laparoscopic sentinel lymph node biopsy
Primary outcomes (1)
- measure
- Completement of performance of laparoscopic sentinel lymph node biopsy
- timeFrame
- within 24 hours after operation
- description
- Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.
Secondary outcomes (1)
- measure
- Detection rate of laparoscopic sentinel lymph node, learning curve
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * gastric adenocarcinoma in preoperative endoscopic biopsy * clinical stage T1-2N0 * long diameter of tumor \<4cm * distance between tumor and pylorus or cardia \>2cm * age: 20-80 * ECOG: 1 or 0 * patients will undergo laparoscopic gastrectomy Exclusion Criteria: * definite criteria of endoscopic submucosal dissection (size\<2cm, differentiated type, no ulcer) * no indication for surgery for cardiovascular, pulmonary disease * pregancy * drug allergy or previous abdominal surgery, radiotherpy
References
Publications (0)
Data not yet available