Braun Enteroenterostomy for Reconstruction after Pylorus-resecting Pancreaticoduodenectomy (BERP) trial

Not Applicable

Recruiting

• Conditions: Surgery - Surgical techniques; Pancreatic Cancer; Cancer - Pancreatic; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000048785
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-17
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Any adult patient undergoing pancreaticoduodenectomy with planned antecolic Billroth II style reconstruction in the setting of malignancy
-Planned open or minimally invasive approach
-Participant able to provide informed consent

Exclusion Criteria

-Planned Roux-en-Y reconstruction
-Pancreatico-gastrostomy
-Age <18years
-Previous diagnosis of gastroparesis
-Known pre-operative HbA1c >7.5%
-Benign pathologies
-Redo surgery
-Participants in another trial that might alter the outcome measures of this trial
-Those who have previously had major upper gastrointestinal procedures
-Inability to provide informed consent or expected lack of compliance with the post-operative regime

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delayed gastric emptying <br>DGE is defined with 3 different grades by the ISGPS.1<br>-Grade A – Nasogastric intubation lasting more than 3 postoperative days, or the inability to tolerate a solid diet by post-operative day 7<br>-Grade B – Nasogastric intubation lasting for 8 to 14 days, the need for reinsertion of the nasogastric tube after 7 days, or the inability to tolerate a solid diet by post-operative day 14<br>-Grade C – Nasogastric intubation lasting more than 14 days, the need for nasogastric reinsertion after 14 days, or the inability to tolerate a solid diet by postoperative day 21. <br>This will be assessed independently by the research team. <br>[Day of surgery, day 1, 8, 15, 22, 30 and day 90 post operation]