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
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: Laparoscopic PPG Procedure: Laparoscopic DG||Phase 3|
Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
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.
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.
Operations are performed according to the allocated group.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Incidence of Dumping syndrome, assessed by Sigstad score (≥7) [ Time Frame: 1 years postoperatively ]
- Relapse-free survival [ Time Frame: 3 years postoperatively ]
- Overall survival [ Time Frame: 3 years postoperatively ]
- Operative morbidity [ Time Frame: 30 days for early morbidity ]
- Operative mortality [ Time Frame: mortality for 90 days ]
- Body weight change [ Time Frame: check at every visit up to 3 years postoperatively ]
- Fat volume change on abdominal CT scan [ Time Frame: check at every 1 year up to 3 years postoperatively ]
- Change of Hemoglobin [ Time Frame: check at every visit up to 3 years postoperatively ]
- Change of Protein [ Time Frame: check at every visit up to 3 years postoperatively ]
- Change of Albumin [ Time Frame: check at every visit up to 3 years postoperatively ]
- QOL measurement (EORTC C30/STO22) (composite) [ Time Frame: 6 month, 1 year, 2 year, 3 year postoperatively ]
- Incidence of gallbladder stone [ Time Frame: check at every 6 months up to 3 years postoperatively ]
- Gross and microscopic changes measured by gastroscopy (composite) [ Time Frame: 1 year, 2 year, 3 year postoperatively ]
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
|Contact: Hyuk-Joon Lee, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Sang-Hoon Ahn, M.D.||email@example.com|
|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 firstname.lastname@example.org|
|Yonsei University Severance Hospital||Not yet recruiting|
|Seoul, Korea, Republic of|
|Principal Investigator:||Hyuk-Joon Lee, M.D., Ph.D.||Seoul National University Hospital|