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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopic PPG; Procedure: Laparoscopic DG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • National Cacner Center
  • Seongnam, Korea, Republic of
    • Department of Surgery, Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 700-721
      • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hyuk-Joon Lee, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: November 1, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: KLASS-04