A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
NCT ID: NCT03624725
Last Updated: 2022-10-05
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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COMPLETED
NA
592 participants
INTERVENTIONAL
2018-04-01
2022-10-01
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
SINGLE
Study Groups
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modified BII+Braun
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
modified BII+Braun
modified BII+Braun digestive tract reconstruction
traditional BII+Braun
traditional BII+Braun digestive tract reconstruct
No interventions assigned to this group
Interventions
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modified BII+Braun
modified BII+Braun digestive tract reconstruction
Eligibility Criteria
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Inclusion Criteria
* Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
* The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
* It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
* Preoperative ECOG performance status score 0/1
* Nutrition risk screening（NRS2002）
* Preoperative ASA score I-III
* Patient informed consent
Exclusion Criteria
* Severe mental illness
* History of upper abdominal surgery
* History of gastric surgery (including ESD/EMR for gastric cancer)
* 3 years of history of other malignant diseases；
* Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
* A history of unstable angina or myocardial infarction within 6 months
* History of cerebral infarction or cerebral hemorrhage within 6 months
* There is a history of sustained systemic corticosteroid treatment within 1 month
* Needs simultaneous surgical treatment of other diseases；
* Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
* Pulmonary function test FEV\<1 predicted value 50%
18 Years
75 Years
ALL
No
Sponsors
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Xue Yingwei
OTHER
Responsible Party
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Xue Yingwei
Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor
Principal Investigators
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Yingwei Xue, doctor
Role: STUDY_DIRECTOR
Director of Gastrointestinal surgery
Locations
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Gastrointestinal surgery of the affiated tumor hospital
Harbin, Helongjiang, China
Countries
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References
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Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
Other Identifiers
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2018-02-R
Identifier Type: -
Identifier Source: org_study_id
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