D2 Versus D1 Gastrectomy of Operable Gastric Cancer

June 10, 2020 updated by: Mohamed El Messiry, Alexandria University

Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity rate
Time Frame: 30 days after surgery
Frequency of early postoperative complications
30 days after surgery
Operative mortality rate
Time Frame: 30 days after surgery
Frequency of early postoperative mortality
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 years Recurrence rate
Time Frame: 5 years after surgery
Frequency of tumor recurrence within 5 years after curative surgery
5 years after surgery
5 years Cancer specific mortality rate
Time Frame: 5 years after surgery
Frequency of Cancer specific mortality within 5 years after curative surgery
5 years after surgery
5 years Disease free survival rate
Time Frame: 5 years after surgery
Percentage of patients survived for 5 years after surgery without tumor recurrence
5 years after surgery
5 years Overall survival rate
Time Frame: 5 years after surgery
Percentage of patients survived for 5 years after surgery with/without tumor recurrence
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Elmessiry, MD, Assistant professor of surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (ACTUAL)

June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302764

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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