Gastric CancerNCT03372681
Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux
A study testing Isoperistaltic Billroth II + Braun anastomosis and Antiperistaltic Billroth II + Braun anastomosis in people with Gastric Cancer and Postoperative Complications, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Postoperative Complications
- What is being tested?
- Isoperistaltic Billroth II + Braun anastomosis and Antiperistaltic Billroth II + Braun anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed as gastric cancer before surgery
- Clinical staging: cT1-4aN0-3M0
- Postoperative evaluation concluded B-II B anastomosis
- Consent assigned
Who cannot join
- Diagnosed with other malignancies within 2 years
- Gastric cancer with clinical staging: cT4b or M1
- Women with pregnancy or breast-feeding
- Emergency procedures
- Consent not assigned
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.
- Conditions
- Gastric Cancer, Postoperative Complications
- Being tested
- Isoperistaltic Billroth II + Braun anastomosis, Antiperistaltic Billroth II + Braun anastomosis
- Keywords
- Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery
- Medical subject headings
- Stomach Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoperistaltic Billroth II + Braun anastomosisProcedure or surgery
Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction
Antiperistaltic Billroth II + Braun anastomosisProcedure or surgery
Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Antiperistaltic | Experimental | In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis Receives: Procedure: Antiperistaltic Billroth II + Braun anastomosis |
| Isoperistaltic | Active comparator | In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis Receives: Procedure: Isoperistaltic Billroth II + Braun anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Reflux Rate
The rate of bile reflux within 1yrs postoperation
Measured: 1 yrs
Secondary outcomes (4)
Disease-free survival
3yrs DFS
Measured: 3yrs
Overall survival
3yrs OS
Measured: 3 yrs
Surgery-related reflux gastritis rate
The rate of surgery-related reflux gastritis rate
Measured: 1yrs
Surgery-related reflux esophagitis rate
The rate of surgery-related reflux esophagitis rate
Measured: 1 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minhua Zheng, M.D. PhD., Study director, MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372681
- Sponsor's protocol ID
- ShanghaiMISC-B2+Braun
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui LH, Son SY, Shin HJ, Byun C, Hur H, Han SU, Cho YK. Billroth II with Braun Enteroenterostomy Is a Good Alternative Reconstruction to Roux-en-Y Gastrojejunostomy in Laparoscopic Distal Gastrectomy. Gastroenterol Res Pract. 2017;2017:1803851. doi: 10.1155/2017/1803851. Epub 2017 Jan 9.
PubMed 28163716In Choi C, Baek DH, Lee SH, Hwang SH, Kim DH, Kim KH, Jeon TY, Kim DH. Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy. J Gastrointest Surg. 2016 Jun;20(6):1083-90. doi: 10.1007/s11605-016-3138-7. Epub 2016 Apr 11.
PubMed 27067234
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
- ClinicalTrials.gov ID
- NCT03372681
- Acronym / sponsor ID
- ShanghaiMISC-B2+Braun
- Conditions
- Gastric Cancer, Postoperative Complications
- Keywords
- Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Dec 2017 (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.
Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiperistaltic | Experimental | Procedure: Antiperistaltic Billroth II + Braun anastomosisIn this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis |
| Isoperistaltic | Active comparator | Procedure: Isoperistaltic Billroth II + Braun anastomosisIn this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically diagnosed as gastric cancer before surgery
- Clinical staging: cT1-4aN0-3M0
- Postoperative evaluation concluded B-II B anastomosis
- Consent assigned
Key exclusion criteria (5 listed)
- Diagnosed with other malignancies within 2 years
- Gastric cancer with clinical staging: cT4b or M1
- Women with pregnancy or breast-feeding
- Emergency procedures
- Consent not assigned
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 |
|---|---|---|
| Isoperistaltic Billroth II + Braun anastomosisLaparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction | Procedure or surgery | Isoperistaltic |
| Antiperistaltic Billroth II + Braun anastomosisLaparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction | Procedure or surgery | Antiperistaltic |
Primary outcome
Postoperative Reflux Rate
Time frame: 1 yrs
The rate of bile reflux within 1yrs postoperation
4 secondary outcomes
Disease-free survival
Time frame: 3yrs
Overall survival
Time frame: 3 yrs
Surgery-related reflux gastritis rate
Time frame: 1yrs
Surgery-related reflux esophagitis rate
Time frame: 1 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Background: PubMed 28163716Cui LH, Son SY, Shin HJ, Byun C, Hur H, Han SU, Cho YK. Billroth II with Braun Enteroenterostomy Is a Good Alternative Reconstruction to Roux-en-Y Gastrojejunostomy in Laparoscopic Distal Gastrectomy. Gastroenterol Res Pract. 2017;2017:1803851. doi: 10.1155/2017/1803851. Epub 2017 Jan 9.
- Background: PubMed 27067234In Choi C, Baek DH, Lee SH, Hwang SH, Kim DH, Kim KH, Jeon TY, Kim DH. Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy. J Gastrointest Surg. 2016 Jun;20(6):1083-90. doi: 10.1007/s11605-016-3138-7. Epub 2016 Apr 11.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Minhua Zheng, M.D. PhD. study director
MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A study testing Isoperistaltic Billroth II + Braun anastomosis and Antiperistaltic Billroth II + Braun anastomosis in people with Gastric Cancer and Postoperative Complications, run by Shanghai Minimally Invasive Surgery Center.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minhua Zheng, M.D. PhD. (+86-13564119545, zmhtiger@yeah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Reflux Rate (time frame: 1 yrs). 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 NCT03372681, which also lists 2 linked publications.
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 14 Dec 2017.