Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer
調査の概要
詳細な説明
Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.
Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Trabzon、七面鳥、61080
- Karadeniz Technical University, Faculty of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients undergoing gastric surgery for gastric cancer
- Histologically proven gastric adenocarcinoma
- Patients over 18 years
- Patients who agreed to participate in the study
Exclusion Criteria:
- patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
- patients received palliative surgery without gastric resection (bypass procedures)
- patients required thoracotomy/thoracoscopy
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Participants with gastric cancer
All consecutive patients undergoing surgery due to gastric cancer will be included in this study.
|
No intervention is planned for the participants for the treatment of gastric cancer.
Treatment decision will be in line with clinical practice guidelines.
Surgical team will be blind to the participant's sarcopenia status.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Postoperative complications
時間枠:within 30 days after surgery
|
complications graded by Clavien-Dindo Complication Classification System
|
within 30 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Length of hospital stay
時間枠:up to 90 days
|
time interval from the date of operation to the date of discharge
|
up to 90 days
|
Mortality
時間枠:within 30 days after surgery
|
Dying after surgery
|
within 30 days after surgery
|
Readmission rate
時間枠:within 30 days after surgery
|
readmission to the hospital because of the adverse events after discharge
|
within 30 days after surgery
|
Incidence of sarcopenia
時間枠:one day before surgery
|
Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People
|
one day before surgery
|
Muscle mass volume
時間枠:one day before surgery
|
muscle mass volume of a cross-sectional computerized- tomography image of the L3, corrected for patient height resulting in L3 muscle index.
|
one day before surgery
|
Psoas muscle mass volume
時間枠:one day before surgery
|
muscle mass volume of Psoas muscle with 3D reconstruction
|
one day before surgery
|
Muscle strength
時間枠:one day before surgery
|
evaluated by handgrip strength test (with digital dynamometer)
|
one day before surgery
|
Physical performance
時間枠:one day before surgery
|
evaluated by 4-meter gait speed test
|
one day before surgery
|
Major complication
時間枠:within 30 days after surgery
|
grade 3 or higher complications graded by Clavien-Dindo Complication Classification System
|
within 30 days after surgery
|
協力者と研究者
捜査官
- 主任研究者:Ali Guner, MD、Karadeniz Technical University Faculty of Medicine
出版物と役立つリンク
一般刊行物
- Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25.
- Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31.
- Guner A. Recent trends of gastric cancer treatment in Turkey. Transl Gastroenterol Hepatol. 2017 Apr 26;2:31. doi: 10.21037/tgh.2017.04.01. eCollection 2017.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
胃癌の臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
No interventionの臨床試験
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
-
University of MichiganNational Institute on Drug Abuse (NIDA)積極的、募集していない
-
University of PittsburghCenters for Disease Control and Prevention募集暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
-
University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
-
Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺