Clinical trial NCT02327481: Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
Official title: Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms Laparoscopy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 438
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the feasibility, safety, and efficacy of 3D Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma (cT1-4aN0-3M0) were studied.

Detailed description: A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3D laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.

Eligibility criteria: Inclusion Criteria:

* (1)Age from over 19 to under 74 years
* (2)cT1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* (3)Heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications
* (4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs
* (5)American Society of Anesthesiology (ASA) score class I, II, or III
* (6)Written informed consent

Exclusion Criteria:

* (1)Women during pregnancy or breast-feeding
* (2)Severe mental disorder
* (3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* (4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
* (5)History of unstable angina or myocardial infarction within the past six months
* (6)History of cerebrovascular accident within the past six months
* (7)History of continuous systematic administration of corticosteroids within one month
* (8)History of previous neoadjuvant chemotherapy or radiotherapy
* (9)T4b tumors
* (10)Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
* (11)FEV1(Forced expiratory volume in one second)\<50% of predicted values

Primary outcomes:
measure: Operating time
timeFrame: 1 day
Secondary outcomes:
measure: Intraoperative situation
timeFrame: 1 day
measure: Postoperative recovery course
timeFrame: 10 days
measure: Complication
timeFrame: 30 days;36 months
measure: The postoperative pathology
timeFrame: 7 days
measure: Inflammatory and immune response
timeFrame: 7 days
measure: Morbidity and mortality
timeFrame: 30 days;36 months
measure: Hospitalization expenses
timeFrame: 1 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 5-year disease free survival rate
timeFrame: 60 months
measure: 5-year overall survival rate
timeFrame: 60 months
measure: Recurrence patterns
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, M.D.,Ph.D.
role: STUDY_CHAIR
References:
citation: Lu J, Xu Y, Wu Y, Huang XY, Xie JW, Wang JB, Lin JX, Li P, Zheng CH, Huang AM, Huang CM. Tumor-infiltrating CD8+ T cells combined with tumor-associated CD68+ macrophages predict postoperative prognosis and adjuvant chemotherapy benefit in resected gastric cancer. BMC Cancer. 2019 Sep 14;19(1):920. doi: 10.1186/s12885-019-6089-z.
citation: Liu ZY, Chen QY, Zhong Q, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Zheng CH, Huang CM, Li P. Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study. Surg Endosc. 2019 Oct;33(10):3425-3435. doi: 10.1007/s00464-018-06640-7. Epub 2019 Feb 26.
citation: Xu BB, Lu J, Zheng ZF, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng CH, Huang CM, Li P. The predictive value of the preoperative C-reactive protein-albumin ratio for early recurrence and chemotherapy benefit in patients with gastric cancer after radical gastrectomy: using randomized phase III trial data. Gastric Cancer. 2019 Sep;22(5):1016-1028. doi: 10.1007/s10120-019-00936-w. Epub 2019 Feb 9.
citation: Zheng CH, Lu J, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Comparison of 3D laparoscopic gastrectomy with a 2D procedure for gastric cancer: A phase 3 randomized controlled trial. Surgery. 2018 Feb;163(2):300-304. doi: 10.1016/j.surg.2017.09.053. Epub 2017 Nov 28.
citation: Lu J, Zheng CH, Zheng HL, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang CM. Randomized, controlled trial comparing clinical outcomes of 3D and 2D laparoscopic surgery for gastric cancer: an interim report. Surg Endosc. 2017 Jul;31(7):2939-2945. doi: 10.1007/s00464-016-5310-2. Epub 2016 Nov 8.