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

The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Delayed Gastric Emptying; Pancreatic Disease
• Intervention / Treatment: Procedure: Braun anastomosis; Procedure: Standard Child reconstruction

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.

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo TM Strijbos, MD; Phone Number: 0031631987808 0031243668086; Email: bo.strijbos@radboudumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • Amsterdam UMC
    • Contact: M G Besselink
  • Amsterdam, Netherlands
    • Not yet recruiting
    • OLVG
    • Contact: M F Gerhards
  • Eindhoven, Netherlands
    • Not yet recruiting
    • Catharina Hospital
    • Contact: I de Hingh
  • Enschede, Netherlands
    • Not yet recruiting
    • Medical spectrum Twente
    • Contact: M Liem
  • Groningen, Netherlands
    • Not yet recruiting
    • Groningen UMC
    • Contact: J M Klaase
  • Leeuwarden, Netherlands
    • Not yet recruiting
    • Medical Center Leeuwarden
    • Contact: E R Manusama
  • Leiden, Netherlands
    • Not yet recruiting
    • LUMC
    • Contact: J SD Mieog
  • Maastricht, Netherlands
    • Not yet recruiting
    • Maastricht UMC+
    • Contact: M den Dulk
  • Nieuwegein, Netherlands
    • Not yet recruiting
    • St Antonius Hospital
    • Contact: H C van Santvoort
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: B TM Strijbos
  • Rotterdam, Netherlands
    • Not yet recruiting
    • Erasmus MC
    • Contact: B Groot Koerkamp
  • Zwolle, Netherlands
    • Not yet recruiting
    • Isala Hospital
    • Contact: V B Nieuwenhuijs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Braun anastomosis; Open pancreatoduodenectomy with Braun enteroenterostomy	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.
Other: Standard Child reconstruction; Open pancreatoduodenectomy only	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Rising Tide Foundation
• Investigators: Principal Investigator: Martijn WJ Stommel, MD, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Prospective studies; Braun anastomosis; Braun enteroenterostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Pancreatic Diseases
• Other Study ID Numbers: NL 82918.091.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No