Clinical trial NCT02892643: Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
Official title: Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 138
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: Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

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 Bundang Hospital Medical Research Collaborating Center.

Each group 69 patients, total 138 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 adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis.

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

Exclusion Criteria:

* Patients are excluded if they meet any of the following criteria:

History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)

Primary outcomes:
measure: Change of Hemoglobin
timeFrame: up to 2 years postoperatively
measure: Vitamin B12 cumulative supplement quantity
timeFrame: up to 2 years postoperatively
Secondary outcomes:
measure: Operative morbidity
timeFrame: 30 days for early morbidity
measure: Operative mortality
timeFrame: mortality for 90 days
measure: QOL measurement
timeFrame: 6 month, 1 year, 2 year, postoperatively
measure: Reflux esophagitis
timeFrame: check at every 12 months up to 2 years postoperatively
measure: Relapse-free survival
timeFrame: 2 years postoperatively
measure: Overall survival
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital, Deajon
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Cancer Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
citation: Hwang SH, Park DJ, Kim HH, Hyung WJ, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee IS, Suh YS, Park JH, Ahn S, Han SU. Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial. J Gastric Cancer. 2022 Apr;22(2):94-106. doi: 10.5230/jgc.2022.22.e8.