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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2500109905 | Other Identifier | Chinese Clinical Trial Registry |
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To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Port Group | Experimental | 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. |
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| Traditional Laparoscopy Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Port Robotic Surgical System | Device | An investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II) | The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis. | Within 30 days postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | The amount of blood lost during the surgical procedure, measured in milliliters (mL). | During the surgical procedure (Day 0). |
| Time to First Flatus | The time from the end of surgery until the participant's first passage of flatus, measured in days. |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian Shen | Contact | +86 139 6888 8872 | shenxian1120@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Traditional Laparoscopic Surgery | Procedure | Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer. |
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| Up to 30 days postoperatively. |
| Total Operation Time | The duration from the initial skin incision to the completion of skin closure, measured in minutes. | During the surgical procedure (Day 0). |
| Conversion Rate | The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors. | During the surgical procedure (Day 0). |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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