Clinical trial · Interventional
Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
NCT03524300CI-TRIAL-00043159unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Robotic Surgery | — | UNRESOLVED | — |
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Assisted Total Gastrectomy | Procedure | — | UNRESOLVED |
| Robotic Assisted Total Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic Assisted Total Gastrectomy
- description
- Robotic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Robotic Assisted Total Gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic Assisted Total Gastrectomy
- description
- Laparoscopic Assisted Total Gastrectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopic Assisted Total Gastrectomy
Primary outcomes (1)
- measure
- 3-year disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age from over 18 to under 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition * The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results. * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) class I to III * Written informed consent Exclusion Criteria: * cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition * Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * Multiple primary cancer * History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) * Gastric multiple primary carcinoma * Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging * History of other malignant disease within the past 5 years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within the past 6 months * History of cerebrovascular accident within the past 6 months * History of continuous systematic administration of corticosteroids within 1 month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of the predicted values
References
Publications (0)
Data not yet available
No reference posted for this study.