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A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer

X

Xue Yingwei

Status

Completed

Conditions

Quality of Life

Treatments

Procedure: modified BII+Braun

Study type

Interventional

Funder types

Other

Identifiers

NCT03624725
2018-02-R

Details and patient eligibility

About

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

Full description

The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction

Enrollment

592 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18<age<75
  • 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

  • Pregnancy or breastfeeding women
  • 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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

592 participants in 2 patient groups

modified BII+Braun
Active Comparator group
Description:
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
Treatment:
Procedure: modified BII+Braun
traditional BII+Braun
No Intervention group
Description:
traditional BII+Braun digestive tract reconstruct

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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