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

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

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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