Clinical trial NCT02464215: Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer
Official title: Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
D2
laparoscopic
open
surgery
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Xuanwu Hospital, Beijing
name: Beijing Tongren Hospital
First posted: 2015-06-08
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

Detailed description: In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5\~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Eligibility criteria: Inclusion Criteria:

1. Age: older than 18 years old，including 18 years old
2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
3. Cancer core: located at lower part of stomach
4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
6. ASA score: ≤ 3;ECOG performance status 0/1
7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
4. Patient who was treated because of systemic inflammatory disease
5. Pregnant patient or lactating women
6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
7. serious mental illness
8. gastric surgery (including for gastric ESD / EMR)
9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
10. other malignant diseases in 5 years
11. have unstable angina or myocardial infarction within six months
12. have cerebral infarction or cerebral hemorrhage within 6 months
13. sustained systemic glucocorticoid treatment history within 1 month
14. have other diseases needed operative treatment at the same time
15. complications (bleeding, perforation, obstruction) required emergency surgery
16. Pulmonary function tests FEV1 \<50% of predicted value.

Primary outcomes:
measure: Postoperative complication rate
timeFrame: 30 days
Secondary outcomes:
measure: 3-year disease free survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
name: Xiangqian Su, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Z, Xing J, Cai J, Zhang Z, Li F, Zhang N, Wu J, Cui M, Liu Y, Chen L, Yang H, Zheng Z, Wang X, Gao C, Wang Z, Fan Q, Zhu Y, Ren S, Zhang C, Liu M, Ji J, Su X. Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial. Surg Endosc. 2019 Jan;33(1):33-45. doi: 10.1007/s00464-018-6391-x. Epub 2018 Nov 1.