Gastrectomy Outcomes in Elderly Patients

NCT05071755 — Unknown, 350 participants, Marmara University

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RegistryNCT05071755, acronym GOE
StatusUnknown
Study typeObservational
Enrollment350 (Estimated)
SponsorMarmara University (Other)
ConditionsGastrectomy, Elderly, Gastric Cancer, Gastric Adenocarcinoma
InterventionsGastrectomy (Procedure)
Datesstart 2021-11-01 (estimated), primary completion 2022-02-01 (estimated), completion 2022-03-01 (estimated), first posted 2021-10-08, last updated 2021-10-19
Locations1 site in Turkey (Türkiye)

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-Summary

In this study, the investigators aimed to identify independent prognostic factors for early postoperative complications and survival in elderly patients (aged ≥65 years) with gastric cancer.

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+Detailed description

Gastric cancer is the 5th most common type of cancer diagnosed worldwide and ranks 3rd in cancer-related deaths. Along with surgical resection, perioperative chemotherapy or chemoradiotherapy are the main treatment method. Various complications can be seen in the postoperative period, mainly pulmonary complications (13%), cardiac complications (6%), intra-abdominal abscesses (4%), and anastomotic leaks (3%). Approximately 5% of the patients die because of postoperative complications. It is known that low body mass index as a patient-specific factor is associated with postoperative complications and poor prognosis.

The incidence of gastric cancer remains relatively high and, with increasing life expectancy, the incidence of gastric cancer in elderly patients is increasing. Characteristics of elderly patients, such as reduced physiological function, poor nutritional status, and surgical trauma from radical gastrectomy, seem to result in higher postoperative morbidity, a longer length of hospital stays, increased healthcare costs, and higher postoperative mortality. Elderly patients may have a worse prognosis compared to younger patients, primarily because of the increased risk of postoperative complications. Perioperative nutritional support and preoperative rehabilitation are beneficial for elderly patients with gastric cancer and may reduce surgical complications and mortality. Although some studies in the literature state that radical surgery can be performed for those aged 80 and over, some studies have argued that complications increase in elderly patients and that surgery should be limited.

Aim of the study is to identify prognostic factors for postoperative outcomes in elderly patients who underwent surgery for gastric cancer.

+Arms and interventions

  • Gastrectomy (Procedure): Radical Total Gastrectomy, Radical Partial gastrectomy (Proximal / Subtotal)

+Outcome measures

Primary outcomes

  • Postoperative complication rate [Within 30 days after surgery]: Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.
  • Postoperative mortality [Within 30 days after surgery]: Mortality during 30 days after surgery.
  • Overall survival [Five years]: Overall survival is defined as the time interval from the time of the radical gastrectomy to the date of all-cause death or the last follow-up.

+Eligibility

Sex: All, ages: 65 Years to 100 Years

Inclusion Criteria:

* Patients aged 65 and older
* Operable patients with histologically confirmed gastric cancer
* Complete follow-up information

Exclusion Criteria:

* Patients under 65 years of age
* Gastric resection for non-neoplastic diseases
* Missing follow-up information

+Locations (1)

FacilityCityCountryStatus
Marmara University Pendik Training and Research HospitalIstanbulTurkey (Türkiye)

+Publications

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
  • Araki I, Hosoda K, Yamashita K, Katada N, Sakuramoto S, Moriya H, Mieno H, Ema A, Kikuchi S, Mikami T, Watanabe M. Prognostic impact of venous invasion in stage IB node-negative gastric cancer. Gastric Cancer. 2015 Apr;18(2):297-305. doi: 10.1007/s10120-014-0362-2. Epub 2014 Apr 1. PMID 24687437
  • Etoh T, Katai H, Fukagawa T, Sano T, Oda I, Gotoda T, Yoshimura K, Sasako M. Treatment of early gastric cancer in the elderly patient: results of EMR and gastrectomy at a national referral center in Japan. Gastrointest Endosc. 2005 Dec;62(6):868-71. doi: 10.1016/j.gie.2005.09.012. PMID 16301028
  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. PMID 19638912
  • Onodera T, Goseki N, Kosaki G. [Prognostic nutritional index in gastrointestinal surgery of malnourished cancer patients]. Nihon Geka Gakkai Zasshi. 1984 Sep;85(9):1001-5. Japanese. PMID 6438478

+Investigators

  • Tevfik Uprak, MD, Principal investigator, Marmara University Pendik Training and Research Hospital