Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients
NCT ID: NCT02246153
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
202 participants
INTERVENTIONAL
2014-09-30
2017-12-31
Brief Summary
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* China has entered the aging society since 1999. Among the GC patients in China, the average age is 65 years old, which makes increasing attempts to explore laparoscopic techniques in the treatment of elderly patients.
* Nowadays, a considerable proportion of elderly patients suffer from multiple diseases, such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative and postoperative complications can not be ignored. Unfortunately, there are rare studies specializing into the LAG for the GC patients of \> 65 years old.
* Accordingly, the comparison of intraoperative and postoperative complications between laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is warranted.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laparoscopic gastrectomy
Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic gastrectomy
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
* The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
Open gastrectomy
Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Open gastrectomy
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
* The type of reconstruction will be selected according to the surgeon's experience.
Interventions
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Laparoscopic gastrectomy
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
* The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
Open gastrectomy
* After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
* The type of reconstruction will be selected according to the surgeon's experience.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
* Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III
* Written informed consent
Exclusion Criteria
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Exclude the early gastric cancer feasible for ESD
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
65 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Guoxin Li
M.D.,Ph.D., F.R.C.S.
Principal Investigators
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Guoxin Li, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital, Southern Medical University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Yu J, Hu J, Huang C, Ying M, Peng X, Wei H, Jiang Z, Du X, Liu Z, Liu H, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. The impact of age and comorbidity on postoperative complications in patients with advanced gastric cancer after laparoscopic D2 gastrectomy: results from the Chinese laparoscropic gastrointestinal surgery study (CLASS) group. Eur J Surg Oncol. 2013 Oct;39(10):1144-9. doi: 10.1016/j.ejso.2013.06.021. Epub 2013 Jul 10.
Luo J, Zhu Y, Liu H, Hu YF, Li TJ, Lin T, Chen T, Chen H, Chen XH, Yu J, Li GX. Morbidity and mortality of elderly patients with advanced gastric cancer after laparoscopy-assisted or open distal gastrectomy: a randomized-controlled trial. Gastroenterol Rep (Oxf). 2018 Nov;6(4):317-319. doi: 10.1093/gastro/goy013. Epub 2018 May 17.
Related Links
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Southern Medical University, China
Nanfang Hospital, China
Chinese Anti-Cancer Association
Other Identifiers
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NFEC-2014-067
Identifier Type: -
Identifier Source: org_study_id
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