Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000048785
Ethics application status
Approved
Date submitted
8/12/2021
Date registered
17/01/2022
Date last updated
4/10/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Braun Enteroenterostomy for Reconstruction after Pylorus-resecting Pancreaticoduodenectomy (BERP) trial
Scientific title
A multicentre randomised controlled trial of the effect of Braun Enteroenterostomy reconstruction on delayed gastric emptying rates after pylorus resecting pancreaticoduodenectomy.
Secondary ID [1] 305987 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BERP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 324609 0
Condition category
Condition code
Cancer 322061 322061 0 0
Pancreatic
Surgery 322196 322196 0 0
Surgical techniques
Oral and Gastrointestinal 322197 322197 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322383 0
Treatment: Surgery
Comparator / control treatment

The control group is Pancreaticoduodenectomy with antecolic Billroth II Gastrojejunostomy without Braun enteroenterostomy
Control group
Active

Outcomes
Primary outcome [1] 329829 0
delayed gastric emptying
DGE is defined with 3 different grades by the ISGPS.1
- Grade A – Nasogastric intubation lasting more than 3 postoperative days, or the inability to tolerate a solid diet by post-operative day 7
- 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
- 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.
This will be assessed independently by the research team.
Timepoint [1] 329829 0
Day of surgery, day 1, 8, 15, 22, 30 and day 90 post operation
Secondary outcome [1] 403982 0
- Time to the first non-liquid meal (days)
Assessed daily by the surgical team as a standard of care
Timepoint [1] 403982 0
During admission starting from day 1 postoperatively
Secondary outcome [2] 403983 0
- Time until nasogastric tube (NG) removed (days)
Assessed daily by the surgical team as a standard of care
Timepoint [2] 403983 0
During hospital admission post surgery
Secondary outcome [3] 403984 0
- Length of stay (days) (including the first day documented ‘ready for rehab’)
Assessed by the research team via hospital medical records system
Timepoint [3] 403984 0
At the time of review day 30 or 90, the EORTC QLQ-C30/PAN 26 will be assessed and any complications and have the participants returned to a hospital.
Secondary outcome [4] 403985 0
- Incidence Grade B/C Pancreatic Leak (ISGPS classification)
Assessed daily by the surgical team as a standard of care
Timepoint [4] 403985 0
Post surgery
Secondary outcome [5] 403986 0
- Time to first passage of wind (days)
Assessed daily by the surgical team as a standard of care
Timepoint [5] 403986 0
During admission and on day 30 the EORTC QLQ-C30/PAN 26 and complications will be asked by the research team via a phone call.
Secondary outcome [6] 403987 0
- Presence of afferent loop syndrome (Proportion)
Assessed daily by the surgical team as a standard of care
Timepoint [6] 403987 0
During admission, day 30 and day 90
Secondary outcome [7] 403988 0
- 90-day mortality
By the research team from hospital medical records
Timepoint [7] 403988 0
On day 90 follow-up
Secondary outcome [8] 405048 0
Pancreatic Cancer Quality of life- EORTC QLQ-C30/PAN 26 questionnaire
Timepoint [8] 405048 0
On day 90 follow-up
By the research team via phone consult or secure email database (REDcap)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The current baseline of DGE incidence with standard Billroth II reconstruction is approximately 30%.20, Literature suggests that BE could reduce DGE rates to somewhere between 10-15%. A single interim analysis is planed once outcome data are available for 102 patients (62 per arm). The study is designed to control the family-wise error rate to 0.025, with an alpha spending of 0.005 at interim and 0.002 at final. The study will have 80% power to detect a DGF incidence of 6.5% in the intervention group at the interim analyses (using a one-sided alpha of 0.005) and a 3.5% rate at the final analysis (using a one-sided alpha of 0.02) 13.5% at the final analysis, and a 10% dropout so therefore 132 patients in each group would need to be randomised making a total of 264 participants required. We have elected to use a one-sided test as repeated research has shown that BE does not increase the incidence of DGE.
An interim analysis will be conducted after outcome data are available for 102 patients. The purpose of the interim analyses will be to assess futility or superiority. The trial will be considered to stop for futility if the conditional power of rejecting the null hypotheses at the final analysis is less than 20%. The trial will be considered to stop for superiority if the one-sided p-value testing the null hypothesis that the DGE incidence rates are the same in both groups using a chi-square test is less than 0.005.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
4/05/2022
Date of last participant enrolment
Anticipated
15/12/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
102
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21294 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 21295 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 21384 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 36165 0
2305 - New Lambton
Recruitment postcode(s) [2] 36166 0
3084 - Heidelberg
Recruitment postcode(s) [3] 36168 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 310328 0
Hospital
Name [1] 310328 0
John Hunter Hospital
Country [1] 310328 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 311455 0
None
Name [1] 311455 0
Address [1] 311455 0
Country [1] 311455 0
Other collaborator category [1] 282083 0
Hospital
Name [1] 282083 0
Austin Health
Address [1] 282083 0
Austin Health
145 Studley Rd,
Heidelberg VIC 3084
Country [1] 282083 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309989 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309989 0
Ethics committee country [1] 309989 0
Australia
Date submitted for ethics approval [1] 309989 0
29/11/2021
Approval date [1] 309989 0
13/12/2021
Ethics approval number [1] 309989 0
2021/ETH11939

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116094 0
Dr David Burnett
Address 116094 0
John Hunter & Belmont Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 116094 0
Australia
Phone 116094 0
+61 477340275
Fax 116094 0
+610249214274
Email 116094 0
[email protected]
Contact person for public queries
Name 116095 0
Natalie Lott
Address 116095 0
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 116095 0
Australia
Phone 116095 0
+61 477340275
Fax 116095 0
+610249214274
Email 116095 0
[email protected]
Contact person for scientific queries
Name 116096 0
David Burnett
Address 116096 0
John Hunter & Belmont Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 116096 0
Australia
Phone 116096 0
+61 477340275
Fax 116096 0
+610249214274
Email 116096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProspective multicentre randomised controlled trial of the effect of B raun Enteroenterostomy in the Reconstruction after Pancreaticoduodenectomy on delayed gastric emptying (DGE): protocol for the BERP study.2022https://dx.doi.org/10.1136/bmjopen-2022-068452
N.B. These documents automatically identified may not have been verified by the study sponsor.