Clinical trial NCT05709197: The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy
Official title: The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Disease
Pancreatic Cancer
Delayed Gastric Emptying
Keywords: Randomized controlled trial
Prospective studies
Braun anastomosis
Braun enteroenterostomy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Rising Tide Foundation
First posted: 2023-02-02
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Delayed gastric emptying (DGE)
timeFrame: During hospitalization
Secondary outcomes:
measure: Pancreatic fistula (POPF)
timeFrame: During hospitalization
measure: Anastomotic leak
timeFrame: During hospitalization
measure: Postoperative complications: incidence and severity
timeFrame: During hospitalization
measure: Number of days participants were hospitalized
timeFrame: During hospitalization
measure: Number of participants with in-hospital mortality
timeFrame: During hospitalization
measure: 30-day mortality
timeFrame: 30 days
measure: Quality of life (QoL) based on five dimensions
timeFrame: Change from baseline at 1 week, at 2 weeks, and 3 months
measure: Participants perceived disease and treatment related quality of life
timeFrame: Change from baseline at 2 weeks, 3 months, and 12 months
measure: Quality of recovery
timeFrame: Change from baseline at 1 week, at 2 weeks, and 3 months
measure: Functional outcome at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: OLVG
city: Eindhoven
country: Netherlands
facility: Catharina hospital
city: Enschede
country: Netherlands
facility: Medical spectrum Twente
city: Groningen
country: Netherlands
facility: Groningen UMC
city: Leeuwarden
country: Netherlands
facility: Medical center Leeuwarden
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Zwolle
country: Netherlands
facility: Isala hospital
Study officials:
affiliation: Radboud University Medical Center
name: Martijn WJ Stommel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: