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| Name | Class |
|---|---|
| Rising Tide Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Braun anastomosis | Experimental | Open pancreatoduodenectomy with Braun enteroenterostomy |
|
| Standard Child reconstruction | Other | Open pancreatoduodenectomy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Braun anastomosis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During hospitalization |
| Anastomotic leak |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo TM Strijbos, MD | Contact | 0031243668086 | 0031631987808 | bo.strijbos@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Martijn WJ Stommel, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Not yet recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41039614 | Derived | Strijbos BTM, Hopstaken JS, Endo C, de Vries M, Atsma F, Adang E, van der Wees P, Besselink MGH, van Santvoort H, den Dulk M, Groot Koerkamp B, Mieog JSD, Zeverijn S, van Laarhoven CJHM, Stommel MWJ; Dutch Pancreatic Cancer Group. The effectiveness of adding Braun anastomosis to standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): study protocol for a multicentre randomised-controlled trial. Trials. 2025 Oct 2;26(1):387. doi: 10.1186/s13063-025-09051-x. |
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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.
|
| Standard Child reconstruction | Procedure | 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). |
|
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. |
| 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. | During hospitalization |
| Number of days participants were hospitalized | The time period in days between hospital admission and discharge from the hospital. | During hospitalization |
| Number of participants with in-hospital mortality | Any death during hospital admission. | During hospitalization |
| 30-day mortality | Any death occurring 30 days after pancreatoduodenectomy. | 30 days |
| Quality of life (QoL) based on five dimensions | The EQ-5D-5L standardized questionnaire will be used. | 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. | Change from baseline at 2 weeks, 3 months, and 12 months |
| Quality of recovery | The QoR-15 standardized questionnaire will be used. | 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"). | 12 months |
| OLVG | Not yet recruiting | Amsterdam | Netherlands |
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| Catharina hospital | Not yet recruiting | Eindhoven | Netherlands |
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| Medical spectrum Twente | Not yet recruiting | Enschede | Netherlands |
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| Groningen UMC | Not yet recruiting | Groningen | Netherlands |
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| Medical center Leeuwarden | Not yet recruiting | Leeuwarden | Netherlands |
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| LUMC | Not yet recruiting | Leiden | Netherlands |
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| Maastricht UMC+ | Not yet recruiting | Maastricht | Netherlands |
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| St Antonius hospital | Not yet recruiting | Nieuwegein | Netherlands |
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| Radboud UMC | Recruiting | Nijmegen | Netherlands |
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| Erasmus MC | Not yet recruiting | Rotterdam | Netherlands |
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| Isala hospital | Not yet recruiting | Zwolle | Netherlands |
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| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D010190 | Pancreatic Neoplasms |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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