NCT05707338

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

January 22, 2023

Last Update Submit

January 22, 2023

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • early postoperative complications

    20 month

Study Arms (2)

laparoscopic group

ACTIVE COMPARATOR
Procedure: Gastrectomy with lymph node dissection

open group

ACTIVE COMPARATOR
Procedure: Gastrectomy with lymph node dissection

Interventions

Gastrectomy with lymph node dissectionPROCEDURE

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).

laparoscopic groupopen group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The study included patients complaining of gastric cancer stage (T1-T2N0M0).The study will start from december 2022 .
  • according to pathological diagnosis after the operation . patients with N1 confirmed pathologically after operation also will be included in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hao Y, Yu P, Qian F, Zhao Y, Shi Y, Tang B, Zeng D, Zhang C. Comparison of laparoscopy-assisted and open radical gastrectomy for advanced gastric cancer: A retrospective study in a single minimally invasive surgery center. Medicine (Baltimore). 2016 Jun;95(25):e3936. doi: 10.1097/MD.0000000000003936.

    PMID: 27336885BACKGROUND

  • Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.

    PMID: 26903580BACKGROUND

  • Katai H, Mizusawa J, Katayama H, Takagi M, Yoshikawa T, Fukagawa T, Terashima M, Misawa K, Teshima S, Koeda K, Nunobe S, Fukushima N, Yasuda T, Asao Y, Fujiwara Y, Sasako M. Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912. Gastric Cancer. 2017 Jul;20(4):699-708. doi: 10.1007/s10120-016-0646-9. Epub 2016 Oct 7.

    PMID: 27718137BACKGROUND

  • Shi Y, Xu X, Zhao Y, Qian F, Tang B, Hao Y, Luo H, Chen J, Yu P. Short-term surgical outcomes of a randomized controlled trial comparing laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer. Surg Endosc. 2018 May;32(5):2427-2433. doi: 10.1007/s00464-017-5942-x. Epub 2017 Dec 12.

    PMID: 29234941BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

GastrectomyLymph Node Excision

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

mahmoud M Ali, assisstant lecturer

CONTACT

01003169674mahmoud.ali@med.sohag.edu.eg

Abdelhafeez H Mohammad, Professor

CONTACT

01143013313

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer of general surgery department, Sohag university hospital

Study Record Dates

First Submitted

January 22, 2023

First Posted

January 31, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2024

Study Completion

January 1, 2025

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share