Quality of LifeNCT03624725
A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
A study testing modified BII+Braun in people with Quality of Life, run by Xue Yingwei at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- modified BII+Braun
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Gastrointestinal surgery of the affiated tumor hospital
Harbin, Helongjiang, 150001
About this study
Official title: 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
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
Read the detailed 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
- Conditions
- Quality of Life
- Being tested
- modified BII+Braun
- Keywords
- Gastric cancer, Quality of life
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified BII+BraunProcedure or surgery
modified BII+Braun digestive tract reconstruction
| Study group | Role | What they receive |
|---|---|---|
| modified BII+Braun | Active comparator | 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 Receives: Procedure: modified BII+Braun |
| traditional BII+Braun | No intervention | traditional BII+Braun digestive tract reconstruct |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The quality of life questionnaire was conducted at six months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Apr 2018
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xue Yingwei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xue Yingwei, The Third Affiliated Hospital of Harbin Medical University
- Investigators
- Yingwei Xue, doctor, Study director, Director of Gastrointestinal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624725
- Sponsor's protocol ID
- 2018-02-R
- Status last verified
- Oct 2022
- First submitted
- 29 Jul 2018
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38421211
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03624725
- Acronym / sponsor ID
- 2018-02-R
- Conditions
- Quality of Life
- Keywords
- Gastric cancer, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Xue YingweiUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified BII+Braun | Active comparator | Procedure: modified BII+BraunThe 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 intervention | –traditional BII+Braun digestive tract reconstruct |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified BII+Braunmodified BII+Braun digestive tract reconstruction | Procedure or surgery | modified BII+Braun |
Primary outcome
Effects of quality of life
Time frame: The quality of life questionnaire was conducted at six months after surgery.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Derived from this study: PubMed 38421211Cai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingwei Xue, doctor study director
Director of Gastrointestinal surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified BII+Braun in people with Quality of Life, run by Xue Yingwei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of quality of life (time frame: The quality of life questionnaire was conducted at six months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.