Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

April 8, 2020 updated by: Mohamed El Messiry, University of Alexandria

Surgical and Oncologic Outcomes After Curative D2 vs D1 Gastrectomy in Operable Gastric Carcinoma, A Randomized Controlled Study in Egyptian Population

Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed gastric carcinoma
  • Potentially operable gastric carcinoma without evidence of distant metastasis

Exclusion Criteria:

  • Complicated gastric cancer (obstructed or perforated)
  • Locally irresectable tumor
  • Previous or coexisting cancer
  • Prior gastric surgery or neoadjuvant chemotherapy
  • Contraindication for major 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D1 lymphadenectomy
Operable gastric cancer was treated by radical gastrectomy and limited D1 lymphadenectomy
Procedure: D1 lymphadenectomy
Radical gastrectomy with D1 lymphadenectomy
Active Comparator: D2 lymphadenectomy
Operable gastric cancer was treated by radical gastrectomy and extended D2 lymphadenectomy
Procedure: D2 lymphadenectomy
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: Within 30 days after surgery
Frequency of early postoperative mortality
Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 years Recurrence rate
Time Frame: 2 years after surgery
Frequency of tumor recurrence within 2 years after curative surgery
2 years after surgery
2 years Cancer specific mortality rate
Time Frame: 2 years after surgery
Frequency of patients died because of gastric cancer within 2 years after curative surgery
2 years after surgery
2 years Disease free survival rate
Time Frame: 2 years after surgery
Percentage of patients survived for 2 years without tumor recurrence
2 years after surgery
2 years Overall survival rate
Time Frame: 2 years after surgery
Percentage of patients survived for 2 years with/without tumor recurrence
2 years after surgery

Collaborators and Investigators

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

Sponsor

University of Alexandria

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)

December 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0302764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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