NCT03909997

Brief Summary

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This is a retrospective cohort study.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration 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

Study Start

First participant enrolled

April 5, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 6, 2019

Last Update Submit

April 9, 2019

Conditions

Gastric CancerEsophagogastric Junction Disorder

Keywords

Stomach neoplasmsgastrectomyRisk factorsmorbidityadenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with severe 30-day or in-hospital morbidity

    Clavien 3 or higher complications

    Perioperative

Secondary Outcomes (1)

  • Median and percentage of patients with long-term survival

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients treated with a gastrectomy for gastric cancer or esophagogastric cancer at a single center are included.

You may qualify if:

  • Patients treated with a gastrectomy for gastric cancer or esophagogastric cancer.
  • Confirmed adenocarcinoma histology.

You may not qualify if:

  • Histology different from adenocarcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sotero del Rio

Santiago, RM, 7501064, Chile

RECRUITING

Related Publications (13)

  • Park DJ, Lee HJ, Kim HH, Yang HK, Lee KU, Choe KJ. Predictors of operative morbidity and mortality in gastric cancer surgery. Br J Surg. 2005 Sep;92(9):1099-102. doi: 10.1002/bjs.4952.

    PMID: 15931657BACKGROUND

  • Onate-Ocana LF, Cortes-Cardenas SA, Aiello-Crocifoglio V, Mondragon-Sanchez R, Ruiz-Molina JM. Preoperative multivariate prediction of morbidity after gastrectomy for adenocarcinoma. Ann Surg Oncol. 2000 May;7(4):281-8. doi: 10.1007/s10434-000-0281-9.

    PMID: 10819368BACKGROUND

  • Bartlett EK, Roses RE, Kelz RR, Drebin JA, Fraker DL, Karakousis GC. Morbidity and mortality after total gastrectomy for gastric malignancy using the American College of Surgeons National Surgical Quality Improvement Program database. Surgery. 2014 Aug;156(2):298-304. doi: 10.1016/j.surg.2014.03.022. Epub 2014 Mar 16.

    PMID: 24947651BACKGROUND

  • Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.

    PMID: 28597328BACKGROUND

  • Lee KG, Lee HJ, Yang JY, Oh SY, Bard S, Suh YS, Kong SH, Yang HK. Risk factors associated with complication following gastrectomy for gastric cancer: retrospective analysis of prospectively collected data based on the Clavien-Dindo system. J Gastrointest Surg. 2014 Jul;18(7):1269-77. doi: 10.1007/s11605-014-2525-1. Epub 2014 May 13.

    PMID: 24820136BACKGROUND

  • Kikuchi H, Miyata H, Konno H, Kamiya K, Tomotaki A, Gotoh M, Wakabayashi G, Mori M. Development and external validation of preoperative risk models for operative morbidities after total gastrectomy using a Japanese web-based nationwide registry. Gastric Cancer. 2017 Nov;20(6):987-997. doi: 10.1007/s10120-017-0706-9. Epub 2017 Mar 11.

    PMID: 28285387BACKGROUND

  • Norero E, Vega EA, Diaz C, Cavada G, Ceroni M, Martinez C, Briceno E, Araos F, Gonzalez P, Baez S, Vinuela E, Caracci M, Diaz A. Improvement in postoperative mortality in elective gastrectomy for gastric cancer: Analysis of predictive factors in 1066 patients from a single centre. Eur J Surg Oncol. 2017 Jul;43(7):1330-1336. doi: 10.1016/j.ejso.2017.01.004. Epub 2017 Feb 10.

    PMID: 28359594BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • Hayashi T, Yoshikawa T, Aoyama T, Ogata T, Cho H, Tsuburaya A. Severity of complications after gastrectomy in elderly patients with gastric cancer. World J Surg. 2012 Sep;36(9):2139-45. doi: 10.1007/s00268-012-1653-6.

    PMID: 22610266BACKGROUND

  • Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.

    PMID: 26352529BACKGROUND

  • Climent M, Hidalgo N, Vidal O, Puig S, Iglesias M, Cuatrecasas M, Ramon JM, Garcia-Albeniz X, Grande L, Pera M. Postoperative complications do not impact on recurrence and survival after curative resection of gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):132-9. doi: 10.1016/j.ejso.2015.08.163. Epub 2015 Sep 3.

    PMID: 26385054BACKGROUND

  • Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Poor survival rate in patients with postoperative intra-abdominal infectious complications following curative gastrectomy for gastric cancer. Ann Surg Oncol. 2013 May;20(5):1575-83. doi: 10.1245/s10434-012-2720-9. Epub 2012 Oct 18.

    PMID: 23076557BACKGROUND

  • Kubota T, Hiki N, Sano T, Nomura S, Nunobe S, Kumagai K, Aikou S, Watanabe R, Kosuga T, Yamaguchi T. Prognostic significance of complications after curative surgery for gastric cancer. Ann Surg Oncol. 2014 Mar;21(3):891-8. doi: 10.1245/s10434-013-3384-9. Epub 2013 Nov 20.

    PMID: 24254205BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Enrique M Norero, MD

    Hospital Sotero Del Rio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique M Norero, MD

CONTACT

56-2-3536601enorero@yahoo.com

Paulina Gonzalez, RN

CONTACT

56-2-3536601pauly_gc@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 10, 2019

Study Start

April 5, 2019

Primary Completion

April 5, 2021

Study Completion

April 5, 2022

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)