None listed
Conditions
Brief summary
The purpose of this study is to examine the effect of the Braun Enteroenterostomy (BE) surgical method during surgery to remove cancer in the pancreas or small intestine. Who is it for? You may be eligible for this study if you are over 18 years of age and will be undergoing surgery to remove cancer in the pancreas or small intestines. Study details All patients will undergo pancreaticoduodenectomy surgery with antecolic Billroth II style reconstruction, as per usual treatment. Patients will be randomly allocated to either have the BE procedure added to their surgery or to not have BE. The BE procedure is by joining the small bowel to the large bowel (also known as Braun Enteroenterostomy). This takes which takes an additional 15 minutes. Hospital data will be collected to assess surgery recovery daily and questionnaires will be given days 30 and 90 after surgery. It is hoped that this research will reveal if adding the BE surgical technique during surgery will improve patient safety and recovery after surgery, and results in better surgical treatment for digestive system cancer.
Interventions
This project will be designed as a multicentre randomised controlled single-blinded study. The study will be conducted in consecutive adults undergoing planned pancreaticoduodenectomy with planned antecolic Billroth II gastrojejunostomy reconstruction in the setting of malignancy involving the stomach, duodenum, pancreas, or bile duct.
Patients will be randomised to:
- Pancreaticoduodenectomy with antecolic Billroth II Gastrojejunostomy plus Braun enteroenterostomy
- Pancreaticoduodenectomy w
This project will be designed as a multicentre randomised controlled single-blinded study. The study will be conducted in consecutive adults undergoing planned pancreaticoduodenectomy with planned antecolic Billroth II gastrojejunostomy reconstruction in the setting of malignancy involving the stomach, duodenum, pancreas, or bile duct. Patients will be randomised to: - Pancreaticoduodenectomy with antecolic Billroth II Gastrojejunostomy plus Braun enteroenterostomy - Pancreaticoduodenectomy with antecolic Billroth II Gastrojejunostomy without Braun enteroenterostomy Patients will be observed daily by the treating team delayed gastric emptying (DGE)Participants will be recruited by the research team. The intervention is by the treating surgeon. The intervention is the operation itself as described by the randomisation. Participants will be checked daily as standard practice. QOL EQ5DL will be asked preoperatively on day 30 and day 90. Day 30 and 90 may be via phone or in follow-up clinics. Location: during pancreaticoduodenectomy with antecolic Billroth II Gastrojejunostomy surgery and throughout the hospital stay and both surgeries are standard operative techniques.
Sponsors
John Hunter Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed