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Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Laparoscopic proximal gastrectomy Procedure: Laparoscopic total gastrectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 27, 2016
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Hemoglobin [ Time Frame: up to 2 years postoperatively ]
    from blood sample

  2. Vitamin B12 cumulative supplement quantity [ Time Frame: up to 2 years postoperatively ]
    from blood sample


Secondary Outcome Measures :
  1. Operative morbidity [ Time Frame: 30 days for early morbidity ]
    Complications occuring after operation

  2. Operative mortality [ Time Frame: mortality for 90 days ]
    Mortality after operation

  3. QOL measurement [ Time Frame: 6 month, 1 year, 2 year, postoperatively ]
    EORTC C30/STO22

  4. 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

  5. Relapse-free survival [ Time Frame: 2 years postoperatively ]
    Relapse-free survival

  6. Overall survival [ Time Frame: 2 years postoperatively ]
    Overall survival


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892643


Locations
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Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of
Keimyung University Hospital
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Eulji University Hospital, Deajon
Daejeon, Korea, Republic of
Chonnam National University Hospital
Hwasun, Korea, Republic of
National Cancer Center
Ilsan, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information
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Responsible Party: Do Joong Park, M.D., Ph.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02892643    
Other Study ID Numbers: B-1609-361-001
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases