Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
1 other identifier
interventional
438
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2021
CompletedApril 7, 2023
April 1, 2023
1.3 years
December 24, 2014
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operating time
Operating time
1 day
Secondary Outcomes (12)
Intraoperative situation
1 day
Postoperative recovery course
10 days
Complication
30 days;36 months
The postoperative pathology
7 days
Inflammatory and immune response
7 days
- +7 more secondary outcomes
Study Arms (2)
3D Laparoscopic Surgery
EXPERIMENTAL3D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
2D Laparoscopic Surgery
ACTIVE COMPARATOR2D Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
Interventions
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
Wei LH, Zheng HL, Liu ZY, Du XQ, Chen CS, Xu BB, Zheng HH, Lin GT, Xie JW, Zheng CH, Wang JB, Huang CM, Li P. Preoperative visceral fat area predicts intraoperative adverse events during lymphadenectomy in laparoscopic gastrectomy for gastric cancer: a post hoc analysis. Surg Endosc. 2025 Apr;39(4):2275-2287. doi: 10.1007/s00464-025-11602-x. Epub 2025 Feb 12.
PMID: 39937241DERIVEDXu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.
PMID: 38980664DERIVEDZhong Q, Chen JY, Shang-Guan ZX, Liu ZY, Lin GT, Wu D, Jiang YM, Wang JB, Lin JX, Chen QY, Lin JL, Xie JW, Li P, Lu J, Huang CM, Zheng CH. Long-term oncological outcomes of 3D versus 2D laparoscopic gastrectomy for gastric cancer: a randomized clinical trial. Gastric Cancer. 2024 May;27(3):598-610. doi: 10.1007/s10120-024-01470-0. Epub 2024 Feb 20.
PMID: 38379100DERIVEDLiu ZY, Chen QY, Zhong Q, Li P, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Huang CM, Zheng CH. Intraoperative Adverse Events, Technical Performance, and Surgical Outcomes in Laparoscopic Radical Surgery for Gastric Cancer: A Pooled Analysis From 2 Randomized Trials. Ann Surg. 2023 Aug 1;278(2):222-229. doi: 10.1097/SLA.0000000000005727. Epub 2022 Oct 17.
PMID: 36250322DERIVEDLu 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.
PMID: 31521128DERIVEDLiu 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.
PMID: 30809728DERIVEDXu 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.
PMID: 30739259DERIVEDZheng 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.
PMID: 29195739DERIVEDLu 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.
PMID: 27826781DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Changming Huang, M.D.,Ph.D.
Fujian Medical University Union Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fujian Medical University Union Hospital
Study Record Dates
First Submitted
December 24, 2014
First Posted
December 30, 2014
Study Start
January 1, 2015
Primary Completion
April 26, 2016
Study Completion
April 26, 2021
Last Updated
April 7, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share