Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer
NCT ID: NCT02289183
Last Updated: 2020-02-05
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
NA
240 participants
INTERVENTIONAL
2015-01-01
2023-12-31
Brief Summary
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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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Totally laparoscopic distal gastrectomy
The totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy will be performed for the treatment of patients with distal gastric cancer assigned to this group.
Totally laparoscopic distal gastrectomy
Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
Laparoscopy-assisted distal gastrectomy
The laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis will be performed for the treatment of patients with distal gastric cancer assigned to this group.
Laparoscopy-assisted distal gastrectomy
Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis
Interventions
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Totally laparoscopic distal gastrectomy
Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
Laparoscopy-assisted distal gastrectomy
Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis
Eligibility Criteria
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Inclusion Criteria
* Primary distal 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 American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent
Exclusion Criteria
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Fujian Medical University Union Hospital
Principal Investigators
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Changming Huang, M.D.,Ph.D.
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Chaohui Zheng, M.D.
Role: STUDY_DIRECTOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Other Identifiers
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2015-01
Identifier Type: -
Identifier Source: org_study_id
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