Gastrectomy Outcomes in Elderly Patients

Gastric Cancer Clinical Trial

— GOE  

Official title:

Gastrectomy Outcomes in Elderly Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05071755
• Other study ID #: 21s01
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2021
• Source: Marmara University
• Contact: Tevfik Uprak, MD
• Phone: 905337273328
• Email: kuprak[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Gastrectomy
• Gastric Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication rate	Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.	Within 30 days after surgery
Primary	Postoperative mortality	Mortality during 30 days after surgery.	Within 30 days after surgery
Primary	Overall survival	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.	Five years