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NCT Number: NCT05253430

D1 vs D2 Lymphadenectomy in Gastric Cancer

This study is a retrospective study with a propensity score-matched analysis in order to balance differences between patients with D1 and D2 lymphadenectomy for gastric cancer.The main aim is to analyse differences in the postoperative and oncological outcomes of patients with gastric cancer (GC) who underwent D1 and D2 gastrectomy.

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

In this propensity score-matched analysis of 128 patients, D2 lymphadenectomy improved long-term outcomes compared with D1 in patients with curative intent surgery for gastric cancer except for the group of patients older than 75 years and with early tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients diagnosed with GC stage I-III who underwent a curative gastrectomy +/- perioperative chemotherapy

Exclusion criteria

  • patients with adenocarcinoma Siewert type I/II, palliative surgery, R1/R2 resections and pathological stage (pStage) IV.

Treatment and study plan

Lymphadenectomy type

Procedure

D1 vs D2 lymph node dissection

Primary outcomes

  1. Disease-free survival

    Time frame: percentage of patients without disease recurrence alive at 3 and 5 years after surgery

    Disease-free survival (DFS) was defined as the time from gastric surgery to the date of recurrence (locoregional, peritoneal recurrence and/or distant metastases).

Secondary outcomes

  1. Overall survival

    Time frame: percentage of patients alive at 3 and 5 years after surgery

    Overall survival (OS) was defined as the time from the date of surgery to the date of death from any cause

  2. Postoperative morbidity

    Time frame: from the surgery up to 90 days after the surgery

    Surgical complications were defined as any deviation from the normal postoperative course within 90 days after surgery, both during the hospital stay or after discharge.

  3. Postoperative mortality

    Time frame: from the surgery up to 90 days after the surgery

    Mortality through post-operative follow-up

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

Prognostic Implications of D1 vs D2 Lymphadenectomy in Gastric Cancer: a Propensity Score Matched Analysis

Important dates

Study start
1990
Primary completion
2019
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Feb 23, 2022

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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