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Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic proximal gastrectomy
Laparoscopic total gastrectomy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients are included in the trial if they meet all of the following criteria:

Histologically proven adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis.

Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score

Exclusion Criteria:

  • Patients are excluded if they meet any of the following criteria:

History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Dong-A University Hospital
  • Dankook University Hospital
  • Keimyung University Hospital
  • Chungnam National University Hospital
  • Eulji University Hospital, Deajon
  • Chonnam National University Hospital
  • National Cancer Center
  • Pusan National University Hospital
  • Seoul National University Bundang Hospital
  • Ewha Womans University Medical Center
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital
  • Yeouido St. Mary's Hospital
  • Yonsei University Severance Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic proximal gastrectomy

Laparoscopic total gastrectomy

Arm Description

Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Outcomes

Primary Outcome Measures

Change of Hemoglobin
from blood sample
Vitamin B12 cumulative supplement quantity
from blood sample

Secondary Outcome Measures

Operative morbidity
Complications occuring after operation
Operative mortality
Mortality after operation
QOL measurement
EORTC C30/STO22
Reflux esophagitis
assessed by Visick score and endoscopic grading according to LA classification
Relapse-free survival
Relapse-free survival
Overall survival
Overall survival

Full Information

First Posted
September 2, 2016
Last Updated
January 4, 2021
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02892643
Brief Title
Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
Official Title
Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (undefined)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Detailed Description
Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated. Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Bundang Hospital Medical Research Collaborating Center. Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher. Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table. Procedure Operations are performed according to the allocated group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic proximal gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Arm Title
Laparoscopic total gastrectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic proximal gastrectomy
Intervention Description
Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic total gastrectomy
Intervention Description
Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Primary Outcome Measure Information:
Title
Change of Hemoglobin
Description
from blood sample
Time Frame
up to 2 years postoperatively
Title
Vitamin B12 cumulative supplement quantity
Description
from blood sample
Time Frame
up to 2 years postoperatively
Secondary Outcome Measure Information:
Title
Operative morbidity
Description
Complications occuring after operation
Time Frame
30 days for early morbidity
Title
Operative mortality
Description
Mortality after operation
Time Frame
mortality for 90 days
Title
QOL measurement
Description
EORTC C30/STO22
Time Frame
6 month, 1 year, 2 year, postoperatively
Title
Reflux esophagitis
Description
assessed by Visick score and endoscopic grading according to LA classification
Time Frame
check at every 12 months up to 2 years postoperatively
Title
Relapse-free survival
Description
Relapse-free survival
Time Frame
2 years postoperatively
Title
Overall survival
Description
Overall survival
Time Frame
2 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are included in the trial if they meet all of the following criteria: Histologically proven adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score Exclusion Criteria: Patients are excluded if they meet any of the following criteria: History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Dankook University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Keimyung University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Eulji University Hospital, Deajon
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Hwasun
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Ilsan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Ewha Womans University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35534447
Citation
Hwang SH, Park DJ, Kim HH, Hyung WJ, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee IS, Suh YS, Park JH, Ahn S, Han SU. Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial. J Gastric Cancer. 2022 Apr;22(2):94-106. doi: 10.5230/jgc.2022.22.e8.
Results Reference
derived

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Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

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