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
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xian Shen
- 전화번호: +86 139 6888 8872
- 이메일: shenxian1120@126.com
연구 장소
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Zhejiang
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Wenzhou, Zhejiang, 중국
- 모병
- The First Affiliated Hospital of Wenzhou Medical University
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연락하다:
- Xian Shen
- 전화번호: +86 139 6888 8872
- 이메일: shenxian1120@126.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single-Port Group
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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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.
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활성 비교기: Traditional Laparoscopy Group
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
기간: Within 30 days postoperatively.
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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.
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Within 30 days postoperatively.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Estimated Blood Loss
기간: During the surgical procedure (Day 0).
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The amount of blood lost during the surgical procedure, measured in milliliters (mL).
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During the surgical procedure (Day 0).
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Time to First Flatus
기간: Up to 30 days postoperatively.
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The time from the end of surgery until the participant's first passage of flatus, measured in days.
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Up to 30 days postoperatively.
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Total Operation Time
기간: During the surgical procedure (Day 0).
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The duration from the initial skin incision to the completion of skin closure, measured in minutes.
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During the surgical procedure (Day 0).
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Conversion Rate
기간: During the surgical procedure (Day 0).
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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.
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During the surgical procedure (Day 0).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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