Short-term Outcomes of Laparoscopic Versus Open Gastrectomy With Lymph Node Dissection for Early Gastric Cancer :a Randomized Controlled Study

January 22, 2023 updated by: Mahmoud Nasser Mohamed Ali, Sohag University

While the incidence of gastric cancer is gradually declining, it is the fifth most common cancer worldwide and the third most common cause of cancer related death worldwide according to GLOBOCAN 2018 data (Rawla P and Barsouk A.,2019).

Laparoscopic distal gastrectomy for early gastric cancer(EGC) was first performed more than 20 years ago (Shi, Y et al.,2018). Laparoscopy-assisted gastrectomy (LAG) for EGC has been confirmed to have oncologic and long-term survival equivalency to the open technique and provide tremendous advantages over open surgery, such as good cosmesis, reduced pain, and shorter hospital stay(Katai H et al.,2017).

Based on the experience of EGC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC). Retrospective studies have assessed the technical and oncological safety of LAG with D2 lymph node dissection for AGC(Hao Y et al .,2016).

Recently, results of two ongoing randomized controlled trials (RCTs) have revealed the surgical safety of laparoscopic distal gastrectomy with D2 lymphadenectomy for AGC . However, laparoscopic gastrectomy for locally advanced disease remains controversial(Hu Y et al.,2016).

Here, we report the short-term surgical outcomes of a RCT comparing laparoscopic and open gastrectomy (OG) with D2 lymph node dissection for EGC, which was designed to assess the technical safety and oncologic feasibility of LAG for EGC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of the work

a prospective randomized controlled trial comparing laparoscopic and open gastrectomy with D2 lymph node dissection for EGC to evaluate technical safety and oncologic feasibility.

The postoperative morbidity and mortality rates will be based on the modified intention-to-treat analysis.

The aim of this study is to compare the operative and short-term oncologic outcomes of laparoscopic versus open resections.

Patients and methods

The study design: : prospective randomized comparative clinical trial study analyzing outcomes of gastrectomy for early gastric cancer using laporoscopy versus open approach. This will be a prospective comparative study at Sohag University Hospital, Egypt and National Cancer Institute(NCI), Cairo university ,Egypt.

Patients were divided randomizly into two groups; the first group included patients who will have laparoscopic gastrectomy (Lap group), and the second group included patients will receive open gastrectomy (Open group).

Study population

The study included patients complaining of gastric cancer stage (T1-T2N0M0).The study will start from december 2022 .

Inclusion criteria: Inclusion criteria were as follows: histologically confirmed adenocarcinoma of the stomach; pathologically confirmed stage T1-T2; no evidence of distant metastasis by means of abdominal computed tomography(CECT) and CT chest ; D2 lymphadenectomy with curative R0

according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study.

The exclusion criteria:

  1. pregnancy
  2. an American Society of Anesthesiologists (ASA) score > 3,
  3. severe mental disorders
  4. prior upper abdominal surgery except laparoscopic cholecystectomy,
  5. presence of other malignancies
  6. a history of chemotherapy or radiation therapy.
  7. unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%)
  8. abdominal wall hernia
  9. diaphragmatic hernia
  10. coagulation disorder
  11. portal hypertension
  12. Advanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis.

Approvals and consents

This study will be done after obtaining approval from the research ethics committee of the Sohag faculty of medicine. A written Informed consent will be obtained from all participants before being enrolled in the study and before performing the procedure after receiving an explanation of the study protocol, including both types of operation and possible complications. The study will be registered at www.clinicaltrials.gov.

Data collection:

Registered data will be collected from the hospital databases, clinical data.

Randomization

Randomization was performed by closed envelopes and was balanced and stratified for proposed type of resection.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abdelhafeez H Mohammad, Professor
  • Phone Number: 01143013313

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study included patients complaining of gastric cancer stage (T1-T2N0M0).The study will start from december 2022 .

Inclusion criteria: Inclusion criteria were as follows: histologically confirmed adenocarcinoma of the stomach; pathologically confirmed stage T1-T2; no evidence of distant metastasis by means of abdominal computed tomography(CECT) and CT chest ; D2 lymphadenectomy with curative R0

according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study.

Exclusion Criteria:

  1. pregnancy
  2. an American Society of Anesthesiologists (ASA) score > 3,
  3. severe mental disorders
  4. prior upper abdominal surgery except laparoscopic cholecystectomy,
  5. presence of other malignancies
  6. a history of chemotherapy or radiation therapy.
  7. unstable angina or myocardial infarction within the past 6 months, severe respiratory disease (forced expiratory volume in 1 s, FEV1 < 50%)
  8. abdominal wall hernia
  9. diaphragmatic hernia
  10. coagulation disorder
  11. portal hypertension
  12. Advanced gastric cancer (stage;T3,T4,N1 to 3 ,M1) based on preoperative diagnosis.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic group
Procedure: Gastrectomy with lymph node dissection

prospective randomized comparative clinical trial study analyzing outcomes of gastrectomy for early gastric cancer using laporoscopy versus open approach. This will be a prospective comparative study at Sohag University Hospital, Egypt and National Cancer Institute(NCI), Cairo university ,Egypt.

Patients were divided randomizly into two groups; the first group included patients who will have laparoscopic gastrectomy (Lap group), and the second group included patients will receive open gastrectomy (Open group).
Active Comparator: open group
Procedure: Gastrectomy with lymph node dissection

prospective randomized comparative clinical trial study analyzing outcomes of gastrectomy for early gastric cancer using laporoscopy versus open approach. This will be a prospective comparative study at Sohag University Hospital, Egypt and National Cancer Institute(NCI), Cairo university ,Egypt.

Patients were divided randomizly into two groups; the first group included patients who will have laparoscopic gastrectomy (Lap group), and the second group included patients will receive open gastrectomy (Open group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
early postoperative complications
Time Frame: 20 month
20 month

Collaborators and Investigators

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

Sponsor

Sohag University

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 (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-01-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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