- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03140189
Robot-assisted IVOR-LEWIS Esophagectomy (RAILE)
Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial
Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.
Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Shanghai, 중국, 200000
- Yajie Zhang
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with histologically proven esophageal malignancy
- All patients were within the American Society of Anesthesiologists (ASA) class I to III
- neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease
Exclusion Criteria:
Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
rate of major postoperative complications
기간: 30 days after surgery
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30 days after surgery
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2차 결과 측정
결과 측정 |
기간 |
---|---|
rate of overall postoperative complications
기간: 30 days after surgery
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30 days after surgery
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rate of 30-day mortality
기간: 30 days after surgery
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30 days after surgery
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operative time
기간: during the operation
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during the operation
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rate of conversion
기간: during the operation
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during the operation
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length of hospital stay
기간: within 30 days after surgery
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within 30 days after surgery
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rate of R0 resection
기간: within 30 days after surgery
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within 30 days after surgery
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number of harvested lymph nodes
기간: within 30 days after surgery
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within 30 days after surgery
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overall survival
기간: 3 years after surgery
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3 years after surgery
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disease-free survival
기간: 3 years after surgery
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3 years after surgery
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Wee JO, Bravo-Iniguez CE, Jaklitsch MT. Early Experience of Robot-Assisted Esophagectomy With Circular End-to-End Stapled Anastomosis. Ann Thorac Surg. 2016 Jul;102(1):253-9. doi: 10.1016/j.athoracsur.2016.02.050. Epub 2016 May 4.
- Park S, Hwang Y, Lee HJ, Park IK, Kim YT, Kang CH. Comparison of robot-assisted esophagectomy and thoracoscopic esophagectomy in esophageal squamous cell carcinoma. J Thorac Dis. 2016 Oct;8(10):2853-2861. doi: 10.21037/jtd.2016.10.39.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
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. .