Clinical trial · Interventional
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
NCT03624725CI-TRIAL-00061248completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modified BII+Braun | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- modified BII+Braun
- 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
- interventionNames
- Procedure: modified BII+Braun
- type
- NO_INTERVENTION
- label
- traditional BII+Braun
- description
- traditional BII+Braun digestive tract reconstruct
Primary outcomes (1)
- measure
- Effects of quality of life
- timeFrame
- The quality of life questionnaire was conducted at six months after surgery.
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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%
References
Publications (1)
- DERIVEDCai 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 38421211