Clinical trial · Interventional
Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
NCT02595086CI-TRIAL-00047887KLASS-04unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic DG | Procedure | — | UNRESOLVED |
| Laparoscopic PPG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic PPG
- 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
- interventionNames
- Procedure: Laparoscopic PPG
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic DG
- 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
- interventionNames
- Procedure: Laparoscopic DG
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPark 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 34487147