Plain English Summary
Background and study aims
This study compares two techniques to assess the tumor after surgery on the pancreas. The goal is to find the best technique to determine the origin of the tumor/cancer.
Who can participate
All patients that undergo resection of the pancreas head (pancreatoduodenectomy) for a (suspected) tumor or cancer older than 18 years.
What does the study involve
Two techniques to investigate the pancreas after surgery will be compared. These two techniques are commonly used worldwide but have not been compared so far.
What are the possible benefits and risks of participating
Since the tumor is only investigated after surgery, there are no adverse effects for a participating individual. Investigation of the tumor is routinely done and does not interfere with the patients treatment after surgery.
Where is the study run from
The lead center is the Amsterdam UMC, location AMC, and in total we expect 4-5 other Dutch centers to collaborate.
Who is funding the study
Investigator initiated and funded.
Who is the main contact
Stijn van Roessel
s.vanroessel@amsterdamumc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Joanne Verheij
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
020 5665650
j.verheij@amc.uva.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
W18_110 # 18.139
Study information
Scientific title
Axial slicing versus bivalving of the pancreatic head in the pathological examination of pancreatoduodenectomy specimens: a multicenter, randomized, controlled study
Acronym
APOLLO
Study hypothesis
Bivalving of the pancreatic head provides more accurate determination of the origin of the primary tumor compared to axial slicing of the pancreatoduodenectomy specimen.
Ethics approval
Approved 06/04/2018, Medical Ethics Review Committee of Academic Medical Center Amsterdam (Amsterdam UMC, location AMC, Ethics Committee, PO Box 22660, 1100 DD, Amsterdam, Netherlands; s.vanroesse@amc.uva.nl; +31 20 566 9111), ref: W18_110 # 18.139
Study design
Multicenter randomized controlled 1:1 ratio superiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
See additional files
Condition
Patients that undergo elective pancreatoduodenectomy for a malignant or premalignant periampullary lesion
Intervention
Participants will be randomised to one of two treatment arms:
1. Axial slicing according to Verbeke: Parallel margins (en face) from the pancreatic neck margin, proximal distal bile duct margin and enteric proximal and distal margin will be taken. Fixation of the specimen in formalin, after that serial specimen slicing in the axial plane in slices of 3-5 millimeter thick after fixation.
2. Bivalving of the pancreatic head according to Adsay: The main pancreatic duct and common bile duct are probed, and the specimen is sliced along the plane defined by both probes and both ducts are longitudinally opened, i.e. bivalving of the pancreatic head.
Remaining part of the pathological examination will be according to local protocols. Macroscopic photos will be taken from the specimens and an expert panel of pathologists will assess the photos.
The randomization process is done centrally by a computer-based system, stratified for center and neoadjuvant treatment (yes/no).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Level of certainty in determining the primary origin of the tumor by 4 pathologists. Pathologists assess the macroscopic photos of each specimen and score how certain they are of the primary origin of the tumor (0-100%) in a survey.
Secondary outcome measures
1) Inter-observer agreement (kappa) among different pathologists in origin of the tumor (by survey)
2) R1 rate for pancreatic and periampullary cancers/lymph node harvest
Both determined during routine pathological examination.
Overall trial start date
06/02/2018
Overall trial end date
01/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients that undergo pancreatoduodenectomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128, 64 in each arm
Total final enrolment
128
Participant exclusion criteria
1. Pancreatoduodenectomy performed for chronic pancreatitis
2. Pancreatoduodenectomy preoperatively confirmed neuro-endocrine tumors and hamoudi / acinar cell tumors
3. Pancreatoduodenectomy performed for tumors outside the periampullary region
Recruitment start date
01/08/2018
Recruitment end date
04/11/2019
Locations
Countries of recruitment
Netherlands
Trial participating centre
Amsterdam UMC, location AMC
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Trial participating centre
Antonius Hospital
Koekoekslaan 1
Nieuwegein
3435CM
Netherlands
Trial participating centre
Erasmus MC
Doctor Molewaterplein 40
Rotterdam
3015GD
Netherlands
Trial participating centre
Radboud UMC
Geert Grooteplein Zuid 10
Nijmegen
6562GA
Netherlands
Sponsor information
Organisation
Amsterdam UMC, location AMC
Sponsor details
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
020 5669111
s.vanroessel@amsterdamumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/03/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12141624_PIS_30Apr2019.pdf Uploaded 23/05/2019