Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy (KLASS-04)

Seoul National University

Status: Unknown

Conditions: Gastric Cancer

Treatments: Procedure: Laparoscopic PPG; Procedure: Laparoscopic DG

Study type: Interventional

Funder types: Other

Identifiers

NCT02595086

KLASS-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Laparoscopic PPG

Experimental group

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

Treatment:

Procedure: Laparoscopic PPG

Laparoscopic DG

Active Comparator group

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

Treatment:

Procedure: Laparoscopic DG