NCT02892643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

September 2, 2016

Last Update Submit

January 4, 2021

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

  • Change of Hemoglobin

    from blood sample

    up to 2 years postoperatively

  • Vitamin B12 cumulative supplement quantity

    from blood sample

    up to 2 years postoperatively

Secondary Outcomes (6)

  • Operative morbidity

    30 days for early morbidity

  • Operative mortality

    mortality for 90 days

  • QOL measurement

    6 month, 1 year, 2 year, postoperatively

  • Reflux esophagitis

    check at every 12 months up to 2 years postoperatively

  • Relapse-free survival

    2 years postoperatively

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic proximal gastrectomy

EXPERIMENTAL

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.

Procedure: Laparoscopic proximal gastrectomy

Laparoscopic total gastrectomy

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic total gastrectomy

Interventions

Laparoscopic proximal gastrectomyPROCEDURE

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.

Laparoscopic proximal gastrectomy
Laparoscopic total gastrectomyPROCEDURE

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.

Laparoscopic total gastrectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Dong-A University Hospital

Busan, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Keimyung University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Eulji University Hospital, Deajon

Daejeon, South Korea

Location

Chonnam National University Hospital

Hwasun, South Korea

Location

National Cancer Center

Ilsan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Ewha Womans University Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Yeouido St. Mary's Hospital

Seoul, South Korea

Location

Yonsei University Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (2)

  • Park DJ, Han SU, Hyung WJ, Hwang SH, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee I, Suh YS, Park JH, Ahn S, Park YS, Kim HH. Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12 Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2256004. doi: 10.1001/jamanetworkopen.2022.56004.

    PMID: 36790808DERIVED

  • 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.

    PMID: 35534447DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

October 27, 2016

Primary Completion

September 17, 2018

Study Completion

September 17, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

KR(16)