Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    proximal gastrectomy | comparison of laparoscopic proximal gastrectomy
Previous Study | Return to List | Next Study

Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892643
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Do Joong Park, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE September 2, 2016
First Posted Date  ICMJE September 8, 2016
Last Update Posted Date January 6, 2021
Study Start Date  ICMJE October 27, 2016
Actual Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Change of Hemoglobin [ Time Frame: up to 2 years postoperatively ]
    from blood sample
  • Vitamin B12 cumulative supplement quantity [ Time Frame: up to 2 years postoperatively ]
    from blood sample
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • Change of Hemoglobin [ Time Frame: up to 2 years postoperatively ]
  • Vitamin B12 cumulative supplement quantity [ Time Frame: up to 2 years postoperatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Operative morbidity [ Time Frame: 30 days for early morbidity ]
    Complications occuring after operation
  • Operative mortality [ Time Frame: mortality for 90 days ]
    Mortality after operation
  • QOL measurement [ Time Frame: 6 month, 1 year, 2 year, postoperatively ]
    EORTC C30/STO22
  • Reflux esophagitis [ Time Frame: check at every 12 months up to 2 years postoperatively ]
    assessed by Visick score and endoscopic grading according to LA classification
  • Relapse-free survival [ Time Frame: 2 years postoperatively ]
    Relapse-free survival
  • Overall survival [ Time Frame: 2 years postoperatively ]
    Overall survival
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • Operative morbidity [ Time Frame: 30 days for early morbidity ]
  • Operative mortality [ Time Frame: mortality for 90 days ]
  • QOL measurement [ Time Frame: 6 month, 1 year, 2 year, postoperatively ]
    EORTC C30/STO22
  • Reflux esophagitis [ Time Frame: check at every 12 months up to 2 years postoperatively ]
    assessed by Visick score and endoscopic grading according to LA classification
  • Relapse-free survival [ Time Frame: 2 years postoperatively ]
  • Overall survival [ Time Frame: 2 years postoperatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
Official Title  ICMJE Multicenter Prospective Randomized Controlled Trial of Comparing Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy for Upper Third Early Gastric Cancer (KLASS-05)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Procedure: 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.
  • Procedure: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Laparoscopic proximal gastrectomy
  • 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.
    Intervention: Procedure: Laparoscopic total gastrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
138
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 17, 2020
Actual Primary Completion Date September 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02892643
Other Study ID Numbers  ICMJE B-1609-361-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Do Joong Park, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP