Clinical trial NCT02595086: Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
Official title: Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Dumping syndrome, assessed by Sigstad score (≥7)
timeFrame: 1 years postoperatively
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 3 years postoperatively
measure: Overall survival
timeFrame: 3 years postoperatively
measure: Operative morbidity
timeFrame: 30 days for early morbidity
measure: Operative mortality
timeFrame: mortality for 90 days
measure: Body weight change
timeFrame: check at every visit up to 3 years postoperatively
measure: Fat volume change on abdominal CT scan
timeFrame: check at every 1 year up to 3 years postoperatively
measure: Change of Hemoglobin
timeFrame: check at every visit up to 3 years postoperatively
measure: Change of Protein
timeFrame: check at every visit up to 3 years postoperatively
measure: Change of Albumin
timeFrame: check at every visit up to 3 years postoperatively
measure: QOL measurement (EORTC C30/STO22) (composite)
timeFrame: 6 month, 1 year, 2 year, 3 year postoperatively
measure: Incidence of gallbladder stone
timeFrame: check at every 6 months up to 3 years postoperatively
measure: Gross and microscopic changes measured by gastroscopy (composite)
timeFrame: 1 year, 2 year, 3 year postoperatively
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Jung-gu
city: Goyang-si
country: Korea, Republic of
facility: National Cacner Center
city: Seongnam
country: Korea, Republic of
facility: Department of Surgery, Seoul National University BUNDANG Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyuk-Joon Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.