Trial Title:
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy
NCT ID:
NCT05709197
Condition:
Pancreatic Disease
Pancreatic Cancer
Delayed Gastric Emptying
Conditions: Official terms:
Pancreatic Diseases
Gastroparesis
Conditions: Keywords:
Randomized controlled trial
Prospective studies
Braun anastomosis
Braun enteroenterostomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Patients will be blinded considering their treatment allocation. The house officer, ward
nurses and data managers who extract data concerning the primary and secondary endpoint
will be blinded for the allocation as well. For this reason, this will be a patient- and
observer blinded RCT.
Intervention:
Intervention type:
Procedure
Intervention name:
Braun anastomosis
Description:
Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique
will not be standardized. In addition to the reconstruction technique used, a
side-to-side anastomosis will be created between the afferent and efferent jejunal limbs
of the gastrojejunostomy (GJ) at 20 cm distance from the GJ. The anastomosis will be
hand-sewn with monofilament PDS 3-0 one-layer running suture.
Arm group label:
Braun anastomosis
Intervention type:
Procedure
Intervention name:
Standard Child reconstruction
Description:
Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique
will not be standardized. The surgeon is able to perform the PD as normally would be done
(antecolic, retrocolic, pylorus-preserving or with distal gastric resecting).
Arm group label:
Standard Child reconstruction
Summary:
The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an
extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic
head resection in reducing the incidence of delayed gastric emptying.
Detailed description:
Rationale/hypothesis: The addition of Braun enteroenterostomy (BE) reduces the incidence
of delayed gastric emptying (DGE) resulting in lower morbidity and healthcare costs after
pancreatoduodenectomy.
Objective: To assess the effectiveness of adding BE in reducing DGE in patients
undergoing open pancreatoduodenectomy.
Study design: A multicenter, patient and observer blinded, registry-based randomized
controlled trial.
Study population: Patients undergoing an open pancreatoduodenectomy for all indications.
Intervention: Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual
care.
Usual care/comparison: Pancreatoduodenectomy with standard Child reconstruction.
Main endpoints:
1. Incidence of DGE Grade B/C (according to International Study Group of Pancreatic
Surgery (ISGPS)
2. Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to
ISGPS), anastomotic leak, complications, hospital length of stay, functional outcome
at 12 months, in-hospital mortality, 30-day mortality, healthcare costs.
Sample size: 256 in total, 128 per arm
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: Patients undergoing open pancreatoduodenectomy have an increased risk
of postoperative complications such as DGE, POPF and anastomotic leak. The addition of
BE, which is an anastomosis, could also result in a leak. However, this risk is
diminishable compared to the risks of DGE and DGE related other complications like
anastomotic leaks associated with standard pancreatoduodenectomy. Moreover, previous
cohort studies involving BE do not describe an increased risk of adverse outcomes for BE.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Undergoing open pancreatoduodenectomy
- Provided informed consent
- Age over 18 years
Exclusion Criteria:
- Insufficient control of the Dutch language to read the patient information and to
fill out the questionnaires in Dutch hospitals
- Previous bariatric surgery (such as Roux-en-Y gastric bypass, gastric sleeve)
- Pregnancy
- Bowel motility disorders
- Minimally invasive pancreatoduodenectomy
- Gastric outlet syndrome
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M G Besselink
Facility:
Name:
OLVG
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M F Gerhards
Facility:
Name:
Catharina hospital
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
I de Hingh
Facility:
Name:
Medical spectrum Twente
Address:
City:
Enschede
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M Liem
Facility:
Name:
Groningen UMC
Address:
City:
Groningen
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
J M Klaase
Facility:
Name:
Medical center Leeuwarden
Address:
City:
Leeuwarden
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
E R Manusama
Facility:
Name:
LUMC
Address:
City:
Leiden
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
J SD Mieog
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
M den Dulk
Facility:
Name:
St Antonius hospital
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
H C van Santvoort
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
B TM Strijbos
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
B Groot Koerkamp
Facility:
Name:
Isala hospital
Address:
City:
Zwolle
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
V B Nieuwenhuijs
Start date:
April 17, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Rising Tide Foundation
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709197
