Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
KLASS-04
Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
1 other identifier
interventional
256
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Jul 2015
Longer than P75 for not_applicable gastric-cancer
5 active sites
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 Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 23, 2020
October 1, 2020
7.9 years
July 2, 2015
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
1 years postoperatively
Secondary Outcomes (12)
Relapse-free survival
3 years postoperatively
Overall survival
3 years postoperatively
Operative morbidity
30 days for early morbidity
Operative mortality
mortality for 90 days
Body weight change
check at every visit up to 3 years postoperatively
- +7 more secondary outcomes
Study Arms (2)
Laparoscopic PPG
EXPERIMENTALLaparoscopy 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 DG
ACTIVE COMPARATORLaparoscopic 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
Interventions
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kyungpook National University Hospital
Daegu, Jung-gu, 700-721, South Korea
National Cacner Center
Goyang-si, South Korea
Department of Surgery, Seoul National University BUNDANG Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 34487147DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyuk-Joon Lee, M.D., Ph.D.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2015
First Posted
November 3, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
October 23, 2020
Record last verified: 2020-10