Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

NCT ID: NCT02595086

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2023-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Laparoscopic PPG

Intervention Type: PROCEDURE

Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.

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

Group Type: ACTIVE_COMPARATOR

Laparoscopic DG

Intervention Type: PROCEDURE

Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.

Interventions

Laparoscopic PPG

Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.

Intervention Type: PROCEDURE

Laparoscopic DG

Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyuk-Joon Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Kyungpook National University Hospital

Daegu, Jung-gu, 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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 34487147 (View on PubMed)

Other Identifiers

KLASS-04

Identifier Type: -

Identifier Source: org_study_id