- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07584577
Evaluation of the Administration of Artificial Nutrition by Feeding Jejunostomy During Neoadjuvant Treatment on Postoperative Morbidity in the Context of Esophageal or Stomach Cancer (FREJENO)
연구 개요
상세 설명
Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.
However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.
An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.
In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Caroline GRONNIER, PhD, MD
- 전화번호: +335-57-62-24-77
- 이메일: caroline.gronnier@chu-bordeaux.fr
연구 연락처 백업
- 이름: Valérie AURILLAC
- 전화번호: +335-57-62-24-77
- 이메일: valerie.aurillac@chu-bordeaux.fr
연구 장소
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Pessac, 프랑스, 33600
- 모병
- Hopîtal du Haut Lévêque
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수석 연구원:
- Caroline GRONNIER, MD, PhD
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연락하다:
- Caroline GRONNIER
- 전화번호: + 33 5 57 65 60 05
- 이메일: caroline.gronnier@chu-bordeaux.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy.
The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.
설명
Inclusion Criteria:
- Patient undergoing surgery for esophageal cancer
- Malnourished patient at the time of management
- Receiving neoadjuvant treatment
Exclusion Criteria:
- Patient not malnourished at the time of management
- Patient who did not receive neoadjuvant treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Control group
patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
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Case group
patients who received enteral or parenteral nutrition during neoadjuvant treatment.
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Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of postoperative complications according to the Clavien classification
기간: Day 30
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Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.
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Day 30
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공동 작업자 및 조사자
수사관
- 수석 연구원: Caroline GRONNIER, MD, PhD, University Hospital, Bordeaux
간행물 및 유용한 링크
일반 간행물
- Mariette C, De Botton ML, Piessen G. Surgery in esophageal and gastric cancer patients: what is the role for nutrition support in your daily practice? Ann Surg Oncol. 2012 Jul;19(7):2128-34. doi: 10.1245/s10434-012-2225-6. Epub 2012 Feb 10.
- Deftereos I, Kiss N, Isenring E, Carter VM, Yeung JM. A systematic review of the effect of preoperative nutrition support on nutritional status and treatment outcomes in upper gastrointestinal cancer resection. Eur J Surg Oncol. 2020 Aug;46(8):1423-1434. doi: 10.1016/j.ejso.2020.04.008. Epub 2020 Apr 18.
- Deftereos I, Yeung JM, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Preoperative Nutrition Intervention in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 15;13(9):3205. doi: 10.3390/nu13093205.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUBX 2025/060
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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