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Trial record 1 of 2 for:    proximal gastrectomy | comparison of laparoscopic proximal gastrectomy
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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 : Unknown
Verified September 2017 by Do Joong Park, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Do Joong Park, Seoul National University Bundang Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.




Primary Outcome Measures :
  1. Change of Hemoglobin [ Time Frame: up to 2 years postoperatively ]
  2. Vitamin B12 cumulative supplement quantity [ Time Frame: up to 2 years postoperatively ]

Secondary Outcome Measures :
  1. Operative morbidity [ Time Frame: 30 days for early morbidity ]
  2. Operative mortality [ Time Frame: mortality for 90 days ]
  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 ]
  6. Overall survival [ Time Frame: 2 years postoperatively ]


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)


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


Contacts
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Contact: Do Joong Park, M.D., Ph.D. +82-31-787-7099 djpark@snubh.org
Contact: Sang Hoon Ahn, M.D. +82-31-787-7106 viscaria@snubh.org

Locations
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Korea, Republic of
Soonchunhyang University Bucheon Hospital Not yet recruiting
Bucheon, Korea, Republic of
Dong-A University Hospital Not yet recruiting
Busan, Korea, Republic of
Dankook University Hospital Not yet recruiting
Cheonan, Korea, Republic of
Keimyung University Hospital Not yet recruiting
Daegu, Korea, Republic of
Eulji University Hospital, Deajon Not yet recruiting
Daejeon, Korea, Republic of
Chungnam National University Hospital Recruiting
Daejon, Korea, Republic of
Chonnam National University Hospital Recruiting
Hwasun, Korea, Republic of
National Cancer Center Not yet recruiting
Ilsan, Korea, Republic of
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Ewha Womans University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Yeouido St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
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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: September 11, 2017
Last Verified: September 2017
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