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Completed

NCT Number: NCT05493358

Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

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Key information

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

Gastric cancer is one of the most common cancers in Vietnam . Despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. For resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent worldwide now.

Laparoscopic gastrectomy for locally advanced gastric cancer AGC have commonly used for treatment of AGC, especially in Japan, Korea and China. However, the real role of laparoscop for treament of (AGC) is still controversial in term of technical feasibility, safety and oncologic aspect for T4a stage.

Paragastric inflammatory strands may occur in T4a tumor so that laparoscopic technique is difficult to radically perform. Peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. Despite, some studies have demonstrated the safety and the short-term benefits of LG for T4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes There are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in Vietnam, most of cases in T4a. The purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical T4A stage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of sT4aN0-3M0 according to the 7th edition of the American Joint Committee on Cancer/Union Internationale Contre le Cancer (AJCC/UICC) staging system

Exclusion criteria

  • intraoperatively detected bulky lymph nodes
  • inadequate lymphadenectomy (D0, D1, D1+)
  • macroscopic residual tumor (R2)
  • an American Society of Anaesthesiology (ASA) score of > IV
  • concurrent cancer or history of previous other cancers
  • previous gastrectomy
  • neoadjuvant chemotherapy
  • complications such as bleeding or perforation required emergency gastrectomy.

Treatment and study plan

Laparoscopic distal gastrectomy

Procedure

Distal gastrectomy and standard D2 lymphadenectomy

Primary outcomes

  1. 5 year overall survival by Kaplan Mayer

    Time frame: 5 year after surgery

    The percentage of people in this study who are alive five years after surgery.

  2. 5 year disease-free survival by Kaplan Mayer

    Time frame: 5 year after surgery

    The percentage of people in this study who are alive without recurrence/metastasis five years after surgery.

Secondary outcomes

  1. 1 year overall survival by Kaplan Mayer

    Time frame: 1 year after surgery

    The percentage of people in this study who are alive one years after surgery.

  2. 3 year overall survival by Kaplan Mayer

    Time frame: 3 year after surgery

    The percentage of people in this study who are alive one years after surgery.

  3. 1 year disease-free survival by Kaplan Mayer

    Time frame: 1 year after surgery

    The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.

  4. 3 year disease-free survival by Kaplan Mayer

    Time frame: 3 year after surgery

    The percentage of people in this study who are alive without recurrence/metastasis one years after surgery.

  5. operative morbidity

    Time frame: 30 days after surgery

    The overall rate of postoperative complications

  6. operative time

    Time frame: intraoperative

    The duration of a surgical procedure in minutes.

  7. operative blood loss

    Time frame: intraoperative

    The amount of blood lost during procedure

  8. time to flatus

    Time frame: 30 days after surgery or until mortality ]

    Number of days from date of surgery until date of flatus

  9. Postoperative hospital length of stay

    Time frame: 30 days after surgery or until mortality

    Number of days from date of surgery until date of discharge or mortality

  10. The percentage of complications with Clavien-Dindo

    Time frame: 30 days after surgery

    The percentage of complication grade by Clavien-Dindo classification

  11. The percentage of pattern of recurrence/metastasis

    Time frame: 5 year after surgery

    The percentage of pattern of recurrence/metastasis during follow up period

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Long-term Outcomes of Open Versus Laparoscopic Distal Gastrectomy for T4a Gastric Cancer: a Propensity Score-matched Cohort Study

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
May 6, 2023

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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