Condition category
Cancer
Date applied
25/04/2019
Date assigned
30/04/2019
Last edited
23/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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

01/12/2019

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

http://www.amsterdamumc.nl

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

01/06/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/05/2019: The participant information sheet was uploaded. 30/04/2019: The public title was changed to correct a typographical error. 30/04/2019: Trial’s existence confirmed by Medical Ethics Review Committee of Academic Medical Center Amsterdam