Clinical trial · Observational
Frailty, Immunonutrition, Surgery Type, and Biologic Recovery in Elderly Gastric Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Gastrectomy | Procedure | — | UNRESOLVED |
| Open Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Laparoscopic Surgery
- description
- 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.
- interventionNames
- Procedure: Laparoscopic Gastrectomy
- label
- Open Surgery
- description
- 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.
- interventionNames
- Procedure: Open Gastrectomy
Primary outcomes (1)
- measure
- Rate of postoperative complication
- timeFrame
- Up to 30 days post-operative
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDSung 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. PMID 33538338
- BACKGROUNDJapanese Gastric Cancer Association. Gastric cancer treatment guidelines 2021. Gastric Cancer. 2022;25:1-21.
- BACKGROUNDMakary 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. PMID 20510798
- BACKGROUNDEthun CG, Bilen MA, Jani AB, et al. Frailty and cancer surgery outcomes. Ann Surg Oncol. 2017;24:2131-2139.
- BACKGROUNDMcIsaac 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. PMID 30048320
- BACKGROUNDShimada 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. PMID 27499306
- BACKGROUNDPartridge 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. PMID 24303856
- 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.