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Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy (KLASS-04)

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic PPG
Laparoscopic DG
Sponsored by
Seoul National University 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 primary gastric adenocarcinoma
  • aged 20-80 years old
  • 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
  • clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
  • location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
  • written signed informed consent

Exclusion Criteria:

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

  • pyloric deformity because peptic ulcer disease
  • previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
  • synchronous lesion of early gastric cancer or adenoma in antrum
  • prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
  • patients who need combined resection (eg. cholecystectomy)
  • vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
  • participated in another clinical trial within the last six months or currently involved patients

Sites / Locations

  • Kyungpook National University Hospital
  • National Cacner Center
  • Department of Surgery, Seoul National University BUNDANG Hospital
  • Seoul National University Hospital
  • Yonsei University Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic PPG

Laparoscopic DG

Arm Description

Laparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed

Laparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference

Outcomes

Primary Outcome Measures

Incidence of Dumping syndrome, assessed by Sigstad score (≥7)

Secondary Outcome Measures

Relapse-free survival
Overall survival
Operative morbidity
Operative mortality
Body weight change
Fat volume change on abdominal CT scan
Change of Hemoglobin
Change of Protein
Change of Albumin
QOL measurement (EORTC C30/STO22) (composite)
Incidence of gallbladder stone
Gross and microscopic changes measured by gastroscopy (composite)

Full Information

First Posted
July 2, 2015
Last Updated
October 21, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02595086
Brief Title
Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
Acronym
KLASS-04
Official Title
Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
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 Hospital Medical Research Collaborating Center. Each group 128 patients, total 256 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
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic PPG
Arm Type
Experimental
Arm Description
Laparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed
Arm Title
Laparoscopic DG
Arm Type
Active Comparator
Arm Description
Laparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic PPG
Intervention Description
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic DG
Intervention Description
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
Primary Outcome Measure Information:
Title
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
Time Frame
1 years postoperatively
Secondary Outcome Measure Information:
Title
Relapse-free survival
Time Frame
3 years postoperatively
Title
Overall survival
Time Frame
3 years postoperatively
Title
Operative morbidity
Time Frame
30 days for early morbidity
Title
Operative mortality
Time Frame
mortality for 90 days
Title
Body weight change
Time Frame
check at every visit up to 3 years postoperatively
Title
Fat volume change on abdominal CT scan
Time Frame
check at every 1 year up to 3 years postoperatively
Title
Change of Hemoglobin
Time Frame
check at every visit up to 3 years postoperatively
Title
Change of Protein
Time Frame
check at every visit up to 3 years postoperatively
Title
Change of Albumin
Time Frame
check at every visit up to 3 years postoperatively
Title
QOL measurement (EORTC C30/STO22) (composite)
Time Frame
6 month, 1 year, 2 year, 3 year postoperatively
Title
Incidence of gallbladder stone
Time Frame
check at every 6 months up to 3 years postoperatively
Title
Gross and microscopic changes measured by gastroscopy (composite)
Time Frame
1 year, 2 year, 3 year 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 primary gastric adenocarcinoma aged 20-80 years old 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 clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification) location of primary tumor; middle third of stomach (more than 5cm away from the pylorus) written signed informed consent Exclusion Criteria: Patients are excluded if they meet any of the following criteria: pyloric deformity because peptic ulcer disease previous gastric surgery (e.g. gastro-jejunostomy, primary closure) synchronous lesion of early gastric cancer or adenoma in antrum prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies patients who need combined resection (eg. cholecystectomy) vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women) participated in another clinical trial within the last six months or currently involved patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Jung-gu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
National Cacner Center
City
Goyang-si
Country
Korea, Republic of
Facility Name
Department of Surgery, Seoul National University BUNDANG Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34487147
Citation
Park DJ, Kim YW, Yang HK, Ryu KW, Han SU, Kim HH, Hyung WJ, Park JH, Suh YS, Kwon OK, Yoon HM, Kim W, Park YK, Kong SH, Ahn SH, Lee HJ. Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial). Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295.
Results Reference
derived

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Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

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