Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic PPG
* Procedure: Laparoscopic DG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic PPG<br>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 | Procedure: Laparoscopic PPG<br>* Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.<br>|
| Active Comparator: Laparoscopic DG<br>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 | Procedure: Laparoscopic DG<br>* Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dumping syndrome, assessed by Sigstad score (≥7) |  | 1 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fat volume change on abdominal CT scan |  | check at every 1 year up to 3 years postoperatively | 
| Change of Hemoglobin |  | check at every visit up to 3 years postoperatively | 
| Change of Protein |  | check at every visit up to 3 years postoperatively | 
| Change of Albumin |  | check at every visit up to 3 years postoperatively | 
| QOL measurement (EORTC C30/STO22) (composite) |  | 6 month, 1 year, 2 year, 3 year postoperatively | 
| Incidence of gallbladder stone |  | check at every 6 months up to 3 years postoperatively | 
| Gross and microscopic changes measured by gastroscopy (composite) |  | 1 year, 2 year, 3 year postoperatively |