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Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy (KLASS-04)

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ClinicalTrials.gov Identifier: NCT02595086
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Laparoscopic PPG Procedure: Laparoscopic DG Phase 3

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 Hospital Medical Research Collaborating Center.

Each group 128 patients, total 256 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 : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial Comparing Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy for the Middle Third Early Gastric Cancer (KLASS-04)
Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Laparoscopic PPG
Laparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed
Procedure: Laparoscopic PPG
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.

Active Comparator: Laparoscopic DG

Laparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference

Procedure: Laparoscopic DG
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.




Primary Outcome Measures :
  1. Incidence of Dumping syndrome, assessed by Sigstad score (≥7) [ Time Frame: 1 years postoperatively ]

Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: 3 years postoperatively ]
  2. Overall survival [ Time Frame: 3 years postoperatively ]
  3. Operative morbidity [ Time Frame: 30 days for early morbidity ]
  4. Operative mortality [ Time Frame: mortality for 90 days ]
  5. Body weight change [ Time Frame: check at every visit up to 3 years postoperatively ]
  6. Fat volume change on abdominal CT scan [ Time Frame: check at every 1 year up to 3 years postoperatively ]
  7. Change of Hemoglobin [ Time Frame: check at every visit up to 3 years postoperatively ]
  8. Change of Protein [ Time Frame: check at every visit up to 3 years postoperatively ]
  9. Change of Albumin [ Time Frame: check at every visit up to 3 years postoperatively ]
  10. QOL measurement (EORTC C30/STO22) (composite) [ Time Frame: 6 month, 1 year, 2 year, 3 year postoperatively ]
  11. Incidence of gallbladder stone [ Time Frame: check at every 6 months up to 3 years postoperatively ]
  12. Gross and microscopic changes measured by gastroscopy (composite) [ Time Frame: 1 year, 2 year, 3 year 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 primary gastric adenocarcinoma
  • aged 20-80 years old
  • 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
  • clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification)
  • location of primary tumor; middle third of stomach (more than 5cm away from the pylorus)
  • written signed informed consent

Exclusion Criteria:

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

  • pyloric deformity because peptic ulcer disease
  • previous gastric surgery (e.g. gastro-jejunostomy, primary closure)
  • synchronous lesion of early gastric cancer or adenoma in antrum
  • prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies
  • patients who need combined resection (eg. cholecystectomy)
  • vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
  • participated in another clinical trial within the last six months or currently involved patients

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): NCT02595086


Contacts
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Contact: Hyuk-Joon Lee, M.D., Ph.D. +82-2-2072-1957 appe98@snu.ac.kr
Contact: Sang-Hoon Ahn, M.D. viscaria@snubh.org

Locations
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Korea, Republic of
Kyungpook National University Hospital Not yet recruiting
Daegu, Jung-gu, Korea, Republic of, 700-721
National Cacner Center Not yet recruiting
Goyang-si, Korea, Republic of
Department of Surgery, Seoul National University BUNDANG Hospital Not yet recruiting
Seongnam, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Joon Lee, MD, PhD       appe98@snu.ac.kr   
Yonsei University Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hyuk-Joon Lee, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02595086    
Other Study ID Numbers: KLASS-04
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: June 2015
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