NCT Number: NCT05709197
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Amsterdam UMC, Amsterdam, Netherlands
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: During hospitalization
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
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 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
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
The time period in days between hospital admission and discharge from the hospital.
Time frame: During hospitalization
Any death during hospital admission.
Time frame: 30 days
Any death occurring 30 days after pancreatoduodenectomy.
Time frame: Change from baseline at 1 week, at 2 weeks, and 3 months
The EQ-5D-5L standardized questionnaire will be used.
Time frame: Change from baseline at 2 weeks, 3 months, and 12 months
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 1 week, at 2 weeks, and 3 months
The QoR-15 standardized questionnaire will be used.
Time frame: 12 months
Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").
Radboud University Medical Center
Other
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial
Acronym: REMBRANDT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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