Clinical trial · Interventional
Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial
A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer
NCT07586384CI-TRIAL-00111538recruitingN/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)
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal 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 Surgical Procedures | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-Port Robotic Surgical System | Device | — | UNRESOLVED |
| Traditional Laparoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single-Port Group
- description
- Participants in this group will undergo radical proximal gastrectomy utilizing the SP1000 single-port surgical platform. The procedure focuses on performing the main surgical maneuvers through a centralized access point to evaluate the safety and clinical performance of the robotic system.
- interventionNames
- Device: Single-Port Robotic Surgical System
- type
- ACTIVE_COMPARATOR
- label
- Traditional Laparoscopy Group
- interventionNames
- Procedure: Traditional Laparoscopic Surgery
Primary outcomes (1)
- measure
- Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
- timeFrame
- Within 30 days postoperatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75 years inclusive. ECOG performance status ≤ 2. Histologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction. Clinical stage cT1-T3, N0-N+, M0. Tumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm. Candidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis. Assessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy. Radiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI). ASA physical status classification ≤ III. Adequate bone marrow, hepatic, renal, cardiac, and pulmonary function. Ability to understand and provide written informed consent. Willingness and ability to comply with the 12-month postoperative follow-up schedule. Exclusion Criteria: * Clinical stage T4 or presence of distant metastasis. Esophageal invasion exceeding 2 cm. History of previous major gastric surgery (e.g., partial or total gastrectomy). Other malignant tumors within the last 5 years. Severe organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis). Requirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction. Pregnant or lactating women. Serious psychiatric disorders or cognitive impairment that interferes with study compliance. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.