NCT04429841

Brief Summary

Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

6 years

First QC Date

June 10, 2020

Last Update Submit

June 10, 2020

Conditions

Gastric Cancer

Keywords

Operable Gastric CancerD2 GastrectomyD1 GastrectomyOperative Mortality & MorbidityOncological Outcomes

Outcome Measures

Primary Outcomes (2)

  • Postoperative morbidity rate

    Frequency of early postoperative complications

    30 days after surgery

  • Operative mortality rate

    Frequency of early postoperative mortality

    30 days after surgery

Secondary Outcomes (4)

  • 5 years Recurrence rate

    5 years after surgery

  • 5 years Cancer specific mortality rate

    5 years after surgery

  • 5 years Disease free survival rate

    5 years after surgery

  • 5 years Overall survival rate

    5 years after surgery

Study Arms (2)

D1 Gastrectomy

Patients are managed by radical gastrectomy with D1 lymphadenectomy

Procedure: Radical gastrectomy with D1 lymphadenectomy

D2 Gastrectomy

Patients are managed by radical gastrectomy with D2 lymphadenectomy

Procedure: Radical gastrectomy with D2 lymphadenectomy

Interventions

Radical gastrectomy with D1 lymphadenectomyPROCEDURE
D1 Gastrectomy
Radical gastrectomy with D2 lymphadenectomyPROCEDURE
D2 Gastrectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II).

You may qualify if:

  • Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years

You may not qualify if:

  • Complicated gastric cancer (obstructed or perforated)
  • Irresectable or metastatic disease
  • Previous or coexisting cancer
  • Prior gastric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Alexandria, Egypt

Location

Related Publications (2)

  • Tamura S, Takeno A, Miki H. Lymph node dissection in curative gastrectomy for advanced gastric cancer. Int J Surg Oncol. 2011;2011:748745. doi: 10.1155/2011/748745. Epub 2011 Jun 14.

    PMID: 22312521BACKGROUND

  • Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.

    PMID: 15082726BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Mohamed Elmessiry, MD

    Assistant Professor of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Surgery

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

January 1, 2010

Primary Completion

January 1, 2016

Study Completion

June 1, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

EG(1)