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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03372681
• Other study ID #: ShanghaiMISC-B2+Braun
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2017
• Last updated: December 10, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2017
• Source: Shanghai Minimally Invasive Surgery Center
• Contact: Minhua Zheng, M.D. PhD.
• Phone: +86-13564119545
• Email: zmhtiger[@]yeah.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 214
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Postoperative Complications
• Stomach Neoplasms

Intervention

Procedure:
• Isoperistaltic Billroth II + Braun anastomosis
Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction
• Antiperistaltic Billroth II + Braun anastomosis
Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Minimally Invasive Surgery Center

References & Publications (2)

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. — View Citation

In 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Reflux Rate	The rate of bile reflux within 1yrs postoperation	1 yrs
Secondary	Disease-free survival	3yrs DFS	3yrs
Secondary	Overall survival	3yrs OS	3 yrs
Secondary	Surgery-related reflux gastritis rate	The rate of surgery-related reflux gastritis rate	1yrs
Secondary	Surgery-related reflux esophagitis rate	The rate of surgery-related reflux esophagitis rate	1 yrs