NCT05071755

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

September 28, 2021

Last Update Submit

October 14, 2021

Conditions

GastrectomyElderlyGastric CancerGastric Adenocarcinoma

Keywords

GastrectomyElderlyGastric CancerPrognosis

Outcome Measures

Primary Outcomes (3)

  • Postoperative complication rate

    Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.

    Within 30 days after surgery

  • Postoperative mortality

    Mortality during 30 days after surgery.

    Within 30 days after surgery

  • 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

Interventions

GastrectomyPROCEDURE

Radical Total Gastrectomy, Radical Partial gastrectomy (Proximal / Subtotal)

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the research consists of patients who underwent gastrectomy with the diagnosis of gastric cancer in the General Surgery Clinic of Marmara University Pendik Training and Research Hospital, aged 65 and older between January 2014 and December 2020.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

  • 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: 21351269BACKGROUND

  • 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: 24687437BACKGROUND

  • 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: 16301028BACKGROUND

  • 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: 19638912BACKGROUND

  • 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: 6438478BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Tevfik Uprak, MD

    Marmara University Pendik Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tevfik Uprak, MD

CONTACT

905337273328kuprak@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 8, 2021

Study Start

November 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

TU(1)