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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic PPG | Experimental | 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 |
|
| Laparoscopic DG | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic PPG | Procedure | Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dumping syndrome, assessed by Sigstad score (≥7) | 1 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | 3 years postoperatively | |
| Overall survival | 3 years postoperatively | |
| Operative morbidity |
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Inclusion Criteria:
Patients are included in the trial if they meet all of the following criteria:
Exclusion Criteria:
Patients are excluded if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyuk-Joon Lee, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | Jung-gu | 700-721 | South Korea | ||
| National Cacner Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34487147 | Derived | Park DJ, Kim YW, Yang HK, Ryu KW, Han SU, Kim HH, Hyung WJ, Park JH, Suh YS, Kwon OK, Yoon HM, Kim W, Park YK, Kong SH, Ahn SH, Lee HJ. Short-term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial). Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Laparoscopic DG | Procedure | Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification. |
|
| 30 days for early morbidity |
| Operative mortality | mortality for 90 days |
| Body weight change | check at every visit up to 3 years postoperatively |
| Fat volume change on abdominal CT scan | check at every 1 year up to 3 years postoperatively |
| Change of Hemoglobin | check at every visit up to 3 years postoperatively |
| Change of Protein | check at every visit up to 3 years postoperatively |
| Change of Albumin | check at every visit up to 3 years postoperatively |
| QOL measurement (EORTC C30/STO22) (composite) | 6 month, 1 year, 2 year, 3 year postoperatively |
| Incidence of gallbladder stone | check at every 6 months up to 3 years postoperatively |
| Gross and microscopic changes measured by gastroscopy (composite) | 1 year, 2 year, 3 year postoperatively |
| Goyang-si |
| South Korea |
| Department of Surgery, Seoul National University BUNDANG Hospital | Seongnam | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |