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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
256
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.
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).
Amsterdam UMC
Amsterdam, Netherlands
NOT_YET_RECRUITINGOLVG
Amsterdam, Netherlands
NOT_YET_RECRUITINGCatharina hospital
Eindhoven, Netherlands
Delayed gastric emptying (DGE)
DGE is defined by the need for maintenance of the nasogastric tube (NGT), need for reinsertion of NGT for persistent vomiting after postoperative day (POD) 7, or inability to tolerate a solid diet.
Time frame: During hospitalization
Pancreatic fistula (POPF)
Any measurable volume of drain output with an amylase level of more than 3 times the upper limit of normal serum amylase and clinically relevant condition or development of the patient directly related to the POPF.
Time frame: During hospitalization
Anastomotic leak
Anastomotic leaks of the hepatojejunostomy (HJ) or Braun enteroenterostomy (BE). Anastomotic leaks of the HJ manifest as bile leakage. This is defined as "fluid with an increased bilirubin concentration in the abdominal drain or in the intra-abdominal fluid on or after postoperative day 3, or as the need for radiologic intervention because of biliary collections or relaparotomy resulting from bile peritonitis. Increased bilirubin in the drain is defined as bilirubin concentration more than 3 times greater than the serum bilirubin concentration. An anastomotic leak of the BE is present when an abdominal CT with contrast shows leakage of contrast from the BE or when during relaparotomy dehiscence of the BE is apparent.
Time frame: During hospitalization
Postoperative complications: incidence and severity
Scored according to the modified Clavien-Dindo classification for surgical complications. Grade III and higher are considered clinically relevant in this study.
Time frame: During hospitalization
Number of days participants were hospitalized
The time period in days between hospital admission and discharge from the hospital.
Time frame: During hospitalization
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Medical spectrum Twente
Enschede, Netherlands
NOT_YET_RECRUITINGGroningen UMC
Groningen, Netherlands
NOT_YET_RECRUITINGMedical center Leeuwarden
Leeuwarden, Netherlands
NOT_YET_RECRUITINGLUMC
Leiden, Netherlands
NOT_YET_RECRUITINGMaastricht UMC+
Maastricht, Netherlands
NOT_YET_RECRUITINGSt Antonius hospital
Nieuwegein, Netherlands
NOT_YET_RECRUITINGRadboud UMC
Nijmegen, Netherlands
RECRUITING...and 2 more locations
Number of participants with in-hospital mortality
Any death during hospital admission.
Time frame: During hospitalization
30-day mortality
Any death occurring 30 days after pancreatoduodenectomy.
Time frame: 30 days
Quality of life (QoL) based on five dimensions
The EQ-5D-5L standardized questionnaire will be used.
Time frame: Change from baseline at 1 week, at 2 weeks, and 3 months
Participants perceived disease and treatment related quality of life
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/PAN26 standardized quality of life questionnaires will be used.
Time frame: Change from baseline at 2 weeks, 3 months, and 12 months
Quality of recovery
The QoR-15 standardized questionnaire will be used.
Time frame: Change from baseline at 1 week, at 2 weeks, and 3 months
Functional outcome at 12 months
Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").
Time frame: 12 months