Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)
2019년 10월 11일 업데이트: Yongxin Zhou, Shanghai Tongji Hospital, Tongji University School of Medicine
Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected.
The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified.
The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes.
It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.
연구 개요
상태
상태
알려지지 않은
정황
정황
개입 / 치료
개입 / 치료
상세 설명
According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion.
The risk and benefit were informed and the informed consent of the subjects was signed.
The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer.
The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed.
Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.
연구 유형
연구 유형
중재적
등록 (예상)
등록
120
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Wenli Wang, Master's degree
- 전화번호: 86021661110 13761295864
- 이메일: Anderson840913@163.com
연구 연락처 백업
- 이름: Yongxin zhou, Doctor
- 전화번호: 13681666828
- 이메일: zhou6302@tongji.edu.cn
연구 장소
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Shanghai
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Shanghai, Shanghai, 중국, 200000
- 모병
- Yongxin Zhou
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연락하다:
- Wenli Wang, Master
- 전화번호: 13761295864
- 이메일: Anderson840913@163.com
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연락하다:
- Shaorui Gu, scholor
- 전화번호: 18351977377
- 이메일: 870005908@qq.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- (1) 18-70 years of age, regardless of gender;
- (2) From May 2019 to December 2021, patients with lung cancer who underwent thoracoscopic pneumonectomy (wedge-shaped, segment and lobe) were admitted to our hospital. Postoperative pathological diagnosis was non-small cell lung cancer. Preoperative pathological staging was T1a-bN0M0 and IA1-2 (pathological staging refers to UICC 8th Edition TNM staging standard for lung cancer).
- (3) In addition to routine examinations, all patients underwent enhanced chest CT, cranial CT/MRI, abdominal B-mode ultrasound, whole body bone isotope scan or PET-CT to exclude distant metastasis.
- (4) Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and sign the informed consent.
Exclusion Criteria:
- (1) Patients with other infectious diseases (inflammation, tuberculosis, etc.) in the thoracic cavity;
- (2) Patients are unwilling to accept the new technique of preserving pulmonary branch of vagus nerve during operation;
- (3) Clinical unstable patients with severe cardiovascular, renal and respiratory system;
- (4) Participated in other clinical trials within 30 days;
- (5) Other reasons why researchers think it is inappropriate to participate in the experiment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
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In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
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실험적: No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
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In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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cough after pulmonary resection
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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(1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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pulmonary infection
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative pneumonia should be considered if there are three or more of the following indicators:
If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics. |
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Atelectasis
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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hydrothorax
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative respiratory failure or ARDS or requiring tracheal intubation
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Tracheal intubation; Ventilator; ICU
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Operation time;
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Operation time;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Intraoperative bleeding volume;
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Intraoperative bleeding volume;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative drainage volume;
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Postoperative drainage volume;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Postoperative mortality
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative mortality
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Postoperative cardiovascular complications
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative cardiovascular complications
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Re-admission ICU rate;
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-admission ICU rate;
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Time of stay in ICU;
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Time of stay in ICU;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Hospitalization days
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization days
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
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Hospitalization expenses
기간: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization expenses
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From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
스폰서
수사관
수사관
- 연구 책임자: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Chen W, Zheng R, Zeng H, Zhang S. Epidemiology of lung cancer in China. Thorac Cancer. 2015 Mar;6(2):209-15. doi: 10.1111/1759-7714.12169. Epub 2015 Mar 2.
- Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
- Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
- Weijs TJ, Goense L, van Rossum PSN, Meijer GJ, van Lier AL, Wessels FJ, Braat MN, Lips IM, Ruurda JP, Cuesta MA, van Hillegersberg R, Bleys RL. The peri-esophageal connective tissue layers and related compartments: visualization by histology and magnetic resonance imaging. J Anat. 2017 Feb;230(2):262-271. doi: 10.1111/joa.12552. Epub 2016 Sep 23.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2019년 1월 1일
기본 완료 (예상)
기본 완료
2021년 1월 30일
연구 완료 (예상)
연구 완료
2022년 1월 31일
연구 등록 날짜
최초 제출
최초 제출
2019년 10월 5일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2019년 10월 11일
처음 게시됨 (실제)
처음 게시됨
2019년 10월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2019년 10월 14일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 11일
마지막으로 확인됨
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2019-LCYJ-006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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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. .