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Completed

NCT Number: NCT04429841

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical gastrectomy with D1 lymphadenectomy

Procedure

Radical gastrectomy with D2 lymphadenectomy

Procedure

Primary outcomes

  1. Postoperative morbidity rate

    Time frame: 30 days after surgery

    Frequency of early postoperative complications

  2. Operative mortality rate

    Time frame: 30 days after surgery

    Frequency of early postoperative mortality

Secondary outcomes

  1. 5 years Recurrence rate

    Time frame: 5 years after surgery

    Frequency of tumor recurrence within 5 years after curative surgery

  2. 5 years Cancer specific mortality rate

    Time frame: 5 years after surgery

    Frequency of Cancer specific mortality within 5 years after curative surgery

  3. 5 years Disease free survival rate

    Time frame: 5 years after surgery

    Percentage of patients survived for 5 years after surgery without tumor recurrence

  4. 5 years Overall survival rate

    Time frame: 5 years after surgery

    Percentage of patients survived for 5 years after surgery with/without tumor recurrence

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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