A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer
1 other identifier
interventional
592
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Apr 2018
Longer than P75 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 29, 2018
CompletedFirst Posted
Study publicly available on registry
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 5, 2022
October 1, 2022
4.5 years
July 29, 2018
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of quality of life
The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe
The quality of life questionnaire was conducted at six months after surgery.
Study Arms (2)
modified BII+Braun
ACTIVE COMPARATORThe 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
traditional BII+Braun
NO INTERVENTIONtraditional BII+Braun digestive tract reconstruct
Interventions
Eligibility Criteria
You may qualify if:
- \<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
You may not qualify if:
- Pregnancy or breastfeeding women
- Severe mental illness
- History of upper abdominal surgery
- History of gastric surgery (including ESD/EMR for gastric cancer)
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xue Yingweilead
Study Sites (1)
Gastrointestinal surgery of the affiated tumor hospital
Harbin, Helongjiang, 150001, China
Related Publications (1)
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.
PMID: 38421211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yingwei Xue, doctor
Director of Gastrointestinal surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Head of Gastrointestinal surgery, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
July 29, 2018
First Posted
August 10, 2018
Study Start
April 1, 2018
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 5, 2022
Record last verified: 2022-10