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Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Distal gastrectomy
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, laparoscopic gastrectomy, T4a stage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
  • Age: 18 - 80 year old
  • Tumor located at the middle or lower third of the stomach
  • Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0
  • ASA score: ≤ 3
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

  • Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer
  • Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  • Pregnant patient
  • Combined resection
  • Total gastrectomy

Sites / Locations

  • University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open distal gastrectomy

Laparoscopic distal gastrectomy

Arm Description

An incision of 15~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth II method was used for gastric reconstruction for most cases

5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3. As a general rule, Billroth II method was used for gastric reconstruction for most cases

Outcomes

Primary Outcome Measures

3 year overall survival by Kaplan Mayer
The percentage of people in this study who are alive three years 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.

Secondary Outcome Measures

operative morbidity
The rate of postoperative bleeding and the rate of postoperative leakage
operative mortality
The rate of postoperative dead
hospital stay
The number of days between surgery and discharge
operative time
The duration of a surgical procedure in minutes.
Resected lymph nodes
the number of lymph nodes harvested after surgery

Full Information

First Posted
May 8, 2020
Last Updated
July 27, 2020
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT04384757
Brief Title
Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer
Official Title
Comparison of Laparoscopic Versus Open Distal Gastrectomy for T4a Gastric Cancer: a Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2020 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage
Detailed Description
Gastric cancer poses a significant public health problem. It 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 in the world now. Since laparoscopic gastrectomy for early gastric cancer (EGC) was firstly reported in 1994 , this technique has become standard for treatment of EGC due to the many advantages of mininally invasive surgery and also in oncologic outcomes. Laparoscopic gastrectomy for advanced gastric cancer AGC was first applied by Uyama in 2000, and then, many surgeons have used it 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. 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 is to compare the technical feasibility, early and long term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in T4A stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, laparoscopic gastrectomy, T4a stage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open distal gastrectomy
Arm Type
Active Comparator
Arm Description
An incision of 15~20 cm length is made in the abdominal midline . Standard distal gastrectomy and omentectomy will be performed with D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, proper hepatic artery) . As a general rule, Billroth II method was used for gastric reconstruction for most cases
Arm Title
Laparoscopic distal gastrectomy
Arm Type
Experimental
Arm Description
5 trocar 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 the right gastroepiploic and the inferior pyloric artery were vascularized and cut at their origin from the gastroduodenal artery, just above the pancreatic head, 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 prepared and separately divided and then the left gastric artery was vascularized to remove group 7. The dissection was continued upward along the proximal branches of splenic vessels to remove group 11p and along the lesser curvature to remove group 1,3. As a general rule, Billroth II method was used for gastric reconstruction for most cases
Intervention Type
Procedure
Intervention Name(s)
Distal gastrectomy
Intervention Description
Distal gastrectomy and standard D2 lymphadenectomy
Primary Outcome Measure Information:
Title
3 year overall survival by Kaplan Mayer
Description
The percentage of people in this study who are alive three years after surgery.
Time Frame
3 year after surgery
Title
3 year relapse-free survival by Kaplan Mayer
Description
The percentage of people in this study who are alive without recurrence three years after surgery.
Time Frame
3 year after surgery
Secondary Outcome Measure Information:
Title
operative morbidity
Description
The rate of postoperative bleeding and the rate of postoperative leakage
Time Frame
30 days after surgery
Title
operative mortality
Description
The rate of postoperative dead
Time Frame
30 days after surgery
Title
hospital stay
Description
The number of days between surgery and discharge
Time Frame
30 days after surgery
Title
operative time
Description
The duration of a surgical procedure in minutes.
Time Frame
intraoperative
Title
Resected lymph nodes
Description
the number of lymph nodes harvested after surgery
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma Age: 18 - 80 year old Tumor located at the middle or lower third of the stomach Preoperative cancer stage (CT scan stage): cT4aN0M0, cT4aN1M0, cT4aN2M0, cT4aN3M0 ASA score: ≤ 3 Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) Exclusion Criteria: Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed gastric cancer Had another treatment methods, such as chemotherapy, immunotherapy, or radiotherapy Pregnant patient Combined resection Total gastrectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long D. Vo, PhD, MD
Phone
+84918133915
Email
long.vd@umc.edu.vn; longvoduy26@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dat Q. Tran, MSc, MD
Phone
+84905621107
Email
tqdat1990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long D. Vo, PhD, MD
Organizational Affiliation
University Medical Center, 215 Hong Bang street, Dist. 5, HCM city, VN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Ho Chi Minh City
State/Province
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long D. Vo, PhD, MD
Phone
+84.918133915
Email
long.vd@umc.edu.vn
First Name & Middle Initial & Last Name & Degree
Dat Q. Tran, MsC, MD
Phone
+84.905621107
Email
dat.tq@umc.edu.vn
First Name & Middle Initial & Last Name & Degree
Long D. Vo, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Waiting for the results of this study

Learn more about this trial

Comparison of Open and Laparoscopic Distal Gastrectomy for T4a Gastric Cancer

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