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Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03372681
Enrollment
214
Registered
2017-12-14
Start date
2018-01-01
Completion date
2022-12-31
Last updated
2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Postoperative Complications

Keywords

Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery

Brief 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. 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.

Interventions

PROCEDUREIsoperistaltic Billroth II + Braun anastomosis

Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction

PROCEDUREAntiperistaltic Billroth II + Braun anastomosis

Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction

Sponsors

Shanghai Minimally Invasive Surgery Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Pathologically diagnosed as gastric cancer before surgery * Clinical staging: cT1-4aN0-3M0 * Postoperative evaluation concluded B-II B anastomosis * Consent assigned

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Reflux Rate1 yrsThe rate of bile reflux within 1yrs postoperation

Secondary

MeasureTime frameDescription
Disease-free survival3yrs3yrs DFS
Overall survival3 yrs3yrs OS
Surgery-related reflux gastritis rate1yrsThe rate of surgery-related reflux gastritis rate
Surgery-related reflux esophagitis rate1 yrsThe rate of surgery-related reflux esophagitis rate

Contacts

Primary ContactMinhua Zheng, M.D. PhD.
zmhtiger@yeah.com+86-13564119545
Backup ContactJing Sun, M.D. PhD.
sj11788@rjh.com+86-13524284622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026