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NCT Number: NCT04340440

Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

D1 lymphadenectomy

Procedure

Radical gastrectomy with D1 lymphadenectomy

D2 lymphadenectomy

Procedure

Radical gastrectomy with D2 lymphadenectomy

Primary outcomes

  1. Postoperative morbidity rate

    Time frame: 30 days after surgery

    Frequency of early postoperative complications

  2. Operative mortality rate

    Time frame: Within 30 days after surgery

    Frequency of early postoperative mortality

Secondary outcomes

  1. 2 years Recurrence rate

    Time frame: 2 years after surgery

    Frequency of tumor recurrence within 2 years after curative surgery

  2. 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

  3. 2 years Disease free survival rate

    Time frame: 2 years after surgery

    Percentage of patients survived for 2 years without tumor recurrence

  4. 2 years Overall survival rate

    Time frame: 2 years after surgery

    Percentage of patients survived for 2 years with/without tumor recurrence

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Apr 10, 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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