Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
2026年9月2日 更新者：Adem Yüksel、Kocaeli City Hospital
The Effects of Multidimensional Frailty Phenotypes, Immunonutritional Status, and Surgical Approach on Biological Recovery in Elderly Patients Undergoing Gastric Cancer Surgery: A Prospective Observational Study
This prospective observational cohort study will evaluate the effects of multidimensional frailty phenotypes, immunonutritional status, and surgical approach on biological recovery in patients aged 60 years and older undergoing surgery for gastric cancer.
Preoperative assessment will include physical and cognitive frailty, nutritional status, handgrip strength, and skeletal muscle characteristics on computed tomography.
Patients will be followed prospectively during the perioperative period, including assessment of inflammatory markers, postoperative complications, delirium, hospital length of stay, and functional recovery.
The study aims to determine whether multidimensional frailty and immunonutritional factors are associated with postoperative outcomes and whether surgical approach influences biological recovery in older patients with gastric cancer.
A total of 328 patients are planned to be included at Kocaeli City Hospital.
調査の概要
詳細な説明
This prospective, observational, analytical cohort study will be conducted at the General Surgery Clinic of Kocaeli City Hospital. The study will include patients aged 60 years and older who have gastric cancer and are scheduled for elective radical gastrectomy. A total of 328 patients are planned to be enrolled.
Preoperative assessment will include multidimensional frailty-related parameters, including the modified Frailty Index-11 (mFI-11), Montreal Cognitive Assessment (MoCA), handgrip strength, Nutritional Risk Screening 2002 (NRS-2002), Prognostic Nutritional Index (PNI), and skeletal muscle characteristics assessed on computed tomography at the L3 level. Baseline neutrophil-to-lymphocyte ratio (NLR) and C-reactive protein (CRP) levels will also be recorded.
Intraoperative data will include surgical approach, operative duration, and intraoperative blood loss. Postoperatively, NLR and CRP will be assessed on postoperative days 1, 3, and 5. Delirium will be evaluated using the Confusion Assessment Method (CAM). Postoperative complications will be recorded according to the Clavien-Dindo classification, together with hospital length of stay and handgrip strength before discharge.
The primary purpose of the study is to evaluate the association between multidimensional frailty phenotypes and postoperative outcomes and biological recovery in older patients undergoing gastric cancer surgery. The study will also investigate whether the surgical approach is associated with differences in biological recovery among patients with different frailty profiles.
研究の種類
観察的
入学 (推定)
328
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Adem Yuksel, Assoc.Prof.
- 電話番号：5053455259
- メール：drademyuksel@gmail.com
研究連絡先のバックアップ
- 名前：Sumru Atak, M.D.
- 電話番号：5546664272
- メール：berilsumru@gmail.com
研究場所
-
-
İZMİT
-
Kocaeli、İZMİT、トルコ（Türkiye）
- Kocaeli City Hospital
-
コンタクト：
- Adem Yuksel, Assoc.Prof.
- 電話番号：+90 505 345 52 59
- メール：drademyuksel@gmail.com
-
主任研究者：
- Adem Yuksel, Assoc.Prof.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population will consist of patients aged 60 years and older with gastric cancer who are scheduled for elective radical gastrectomy at the General Surgery Clinic of Kocaeli City Hospital.
Eligible participants will be enrolled prospectively according to the predefined inclusion and exclusion criteria.
A total of 328 participants are planned to be included.
説明
Inclusion Criteria:
- Age 60 years or older.
- Histopathological or endoscopic diagnosis of gastric cancer.
- Planned elective radical gastrectomy.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Stage IV metastatic gastric cancer.
- Requirement for emergency surgery.
- Severe neurological or psychiatric disease preventing completion of cognitive testing.
- Incomplete clinical data.
- Refusal to participate in the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
Laparoscopic Surgery
Patients undergoing elective radical gastrectomy through a laparoscopic approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
|
Elective radical gastrectomy performed using a laparoscopic approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
|
Open Surgery
Patients undergoing elective radical gastrectomy through an open approach.
The surgical approach is determined by routine clinical practice and is not assigned by the study.
|
Elective radical gastrectomy performed using an open approach as part of routine clinical care.
The surgical approach is not assigned by the study
|
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 |
|---|---|---|
|
Rate of postoperative complication
時間枠：Up to 30 days post-operative
|
According to the Clavien-Dindo classification, the status of postoperative complications during index hospitalisation.
|
Up to 30 days post-operative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of Changes in the Neutrophil-to-Lymphocyte Ratio (NLR)
時間枠：Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Change in neutrophil-to-lymphocyte ratio from preoperative baseline to postoperative days 1, 3, and 5
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in C-reactive protein (CRP) levels during the postoperative period compared with baseline values
時間枠：Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
Change in C-reactive protein from preoperative baseline to postoperative days 1, 3, and 5.
|
Preoperative baseline, day 1 post-operative, day 3 post-operative, day 5 post-operative
|
|
Rate of postoperative delirium
時間枠：Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
Occurrence of postoperative delirium assessed daily using the Confusion Assessment Method.
|
Day 1 post-operative, day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative.
|
|
Comparison of length of stay in hospital
時間枠：From date of surgery until date of hospital discharge, assessed up to 3 months
|
Hospital length of stay measured in days from surgery to hospital discharge.
|
From date of surgery until date of hospital discharge, assessed up to 3 months
|
|
Comparison of changes in hand grip strength
時間枠：Baseline, pre-discharge
|
Change in handgrip strength from the preoperative assessment to the pre-discharge assessment
|
Baseline, pre-discharge
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Adem Yuksel, Assoc.Prof.、Kocaeli City Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494.
- McIsaac DI, Taljaard M, Bryson GL, Beaule PE, Gagne S, Hamilton G, Hladkowicz E, Huang A, Joanisse JA, Lavallee LT, MacDonald D, Moloo H, Thavorn K, van Walraven C, Yang H, Forster AJ. Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study. Ann Surg. 2020 Feb;271(2):283-289. doi: 10.1097/SLA.0000000000002967.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Japanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
- Ethun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
- Shimada H, Makizako H, Lee S, Doi T, Lee S, Tsutsumimoto K, Harada K, Hotta R, Bae S, Nakakubo S, Harada K, Suzuki T. Impact of Cognitive Frailty on Daily Activities in Older Persons. J Nutr Health Aging. 2016;20(7):729-35. doi: 10.1007/s12603-016-0685-2.
- Jia G, Li K. Prognostic Nutritional Index is A Useful Predictive Marker for Morbidity and Mortality in Surgery for Perforated Peptic Ulcer. J Inflamm Res. 2025 Aug 14;18:11021-11028. doi: 10.2147/JIR.S519037. eCollection 2025.
- Kanasaki H, Oride A, Miyazaki K. Laparoscopic surgery in elderly patients aged 65 years and older with gynecologic disease. ISRN Obstet Gynecol. 2012;2012:678201. doi: 10.5402/2012/678201. Epub 2012 Nov 21.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2026年8月25日
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-194 (Medical Ethics Committee of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
There is no plan to share individual participant data with other researchers.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。