NCT06202105

Brief Summary

Evidence of implementation of laparoscopic total gastrectomy (LTG) for locally advanced gastric cancer (GC) remains inadequate. This study aimed to compare short- and mid-term outcomes of LTG versus open total gastrectomy (OTG) for cT2-4a GC.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
76mo left

Started Aug 2024

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Study Progress22%
Aug 2024Aug 2032

First Submitted

Initial submission to the registry

December 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2032

Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

8 years

First QC Date

December 30, 2023

Last Update Submit

December 30, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • 3 year overall survival by Kaplan Mayer

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

    3 year after surgery

  • 3 year relapse-free survival by Kaplan Mayer

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

    3 year after surgery

Secondary Outcomes (5)

  • operative morbidity

    30 days after surgery

  • operative mortality

    30 days after surgery

  • operative time

    intraoperative

  • Resected lymph nodes

    intraoperative

  • hospital stay

    30 days after surgery

Study Arms (2)

Laparoscopic total gastrectomy

EXPERIMENTAL

5 trocars were used. The gastrocolic ligament was divided along the border of the transverse colon. ligating the left gastroepiploic vessels to remove group 4sb. The right gastroepiploic vein was divided and right gastroepiploic and inferior pyloric artery were transected at their origin from the gastroduodenal artery to dissect group 6. The dissection was continued along the hepatoduodenal ligament to removed group 5 and group 12a and along the common hepatic artery to remove group 8a and along the celiac axis to remove group 9. The left gastric vein was divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the splenic artery and its branches to remove group 11p,d and/or along the splenic hilum to remove group 10. The dissection was then conducted the right and left of the esophago-gastric junction to remove group 1,2. As a general rule, Roux en Y method was used for esophagoo-jejunal reconstruction for all cases

Procedure: Laparoscopic gastrectomy

Open total gastrectomy

ACTIVE COMPARATOR

An incision of 15\~20 cm length is made in the abdominal midline . Standard total gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, along splenic artery, proper hepatic artery, and/or the splenic hilum) . Roux-en Y esophagojejunal anastomosis is performed for reconstruction.

Procedure: Laparoscopic gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE

Gastrectomy with laparoscopic approach

Laparoscopic total gastrectomyOpen total gastrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
  • Age: 18 - 80 year old
  • Tumor required total gastrectomy for radical treatment
  • Preoperative cancer stage (CT scan stage): cT2-4aNanyM0
  • ASA score: ≤ 3
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

You may not qualify if:

  • Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer
  • Bulky lymph node andd/or Para-aortic lymph node metastasis
  • Combined esophagectomy due to invading to the esophagus
  • Pregnant patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dong Nai General Hospital

Biên Hòa, Dong Nai, 810000, Vietnam

RECRUITING

108 Military Central Hospital

Hà Nội, 100000, Vietnam

NOT YET RECRUITING

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 11, 2024

Study Start

August 2, 2024

Primary Completion (Estimated)

August 2, 2032

Study Completion (Estimated)

August 2, 2032

Last Updated

January 1, 2025

Record last verified: 2024-12

Locations

VN(3)