The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

Pancreatic Cancer Clinical Trial

— REMBRANDT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709197
• Other study ID #: NL 82918.091.22
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: Bo TM Strijbos, MD
• Phone: 0031243668086
• Email: bo.strijbos[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Gastroparesis
• Pancreatic Cancer
• Pancreatic Disease
• Pancreatic Diseases

Intervention

Procedure:
• Braun 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.
• Standard 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).

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	Catharina hospital	Eindhoven
Netherlands	Medical spectrum Twente	Enschede
Netherlands	Groningen UMC	Groningen
Netherlands	Medical center Leeuwarden	Leeuwarden
Netherlands	LUMC	Leiden
Netherlands	Maastricht UMC+	Maastricht
Netherlands	St Antonius hospital	Nieuwegein
Netherlands	Radboud UMC	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Isala hospital	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Rising Tide Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	During hospitalization
Secondary	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
Secondary	Number of days participants were hospitalized	The time period in days between hospital admission and discharge from the hospital.	During hospitalization
Secondary	Number of participants with in-hospital mortality	Any death during hospital admission.	During hospitalization
Secondary	30-day mortality	Any death occurring 30 days after pancreatoduodenectomy.	30 days
Secondary	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
Secondary	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
Secondary	Quality of recovery	The QoR-15 standardized questionnaire will be used.	Change from baseline at 1 week, at 2 weeks, and 3 months
Secondary	Functional outcome at 12 months	Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").	12 months