Delayed Gastric Emptying, Pancreatic Cancer, Pancreatic Disease
Conditions
Keywords
Randomized controlled trial, Prospective studies, Braun anastomosis, Braun enteroenterostomy
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.
Interventions
PROCEDUREBraun anastomosis
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.
PROCEDUREStandard Child reconstruction
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).
Sponsors
Radboud University Medical Center
Rising Tide Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed gastric emptying (DGE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic fistula (POPF) | 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. |
| Anastomotic leak | 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. |
| Postoperative complications: incidence and severity | During hospitalization | Scored according to the modified Clavien-Dindo classification for surgical complications. Grade III and higher are considered clinically relevant in this study. |
| Number of days participants were hospitalized | During hospitalization | The time period in days between hospital admission and discharge from the hospital. |
| Number of participants with in-hospital mortality | During hospitalization | Any death during hospital admission. |
| 30-day mortality | 30 days | Any death occurring 30 days after pancreatoduodenectomy. |
| Quality of life (QoL) based on five dimensions | Change from baseline at 1 week, at 2 weeks, and 3 months | The EQ-5D-5L standardized questionnaire will be used. |
| Participants perceived disease and treatment related quality of life | 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. |
| Quality of recovery | Change from baseline at 1 week, at 2 weeks, and 3 months | The QoR-15 standardized questionnaire will be used. |
| Functional outcome at 12 months | 12 months | Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome"). |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORMartijn WJ Stommel, MD, PhD
Radboud University Medical Center
Outcome results
None listed