Comparing two slicing techniques in the pathological assessment of pancreas specimens in persons who undergo a Whipple resection
| ISRCTN | ISRCTN12141624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12141624 |
| Secondary identifying numbers | W18_110 # 18.139 |
- Submission date
- 25/04/2019
- Registration date
- 30/04/2019
- Last edited
- 05/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | 020 5665650 |
|---|---|
| j.verheij@amc.uva.nl |
Study information
| Study design | Multicenter randomized controlled 1:1 ratio superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN12141624_PIS_30Apr2019.pdf |
| Scientific title | Axial slicing versus bivalving of the pancreatic head in the pathological examination of pancreatoduodenectomy specimens: a multicenter, randomized, controlled study |
| Study acronym | APOLLO |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 06/02/2018 |
| Completion date | 01/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128, 64 in each arm |
| Total final enrolment | 128 |
| Key inclusion criteria | 1. All patients that undergo pancreatoduodenectomy |
| Key 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 |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 04/11/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Amsterdam
1105AZ
Netherlands
Nieuwegein
3435CM
Netherlands
Rotterdam
3015GD
Netherlands
Nijmegen
6562GA
Netherlands
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | 020 5669111 |
|---|---|
| s.vanroessel@amsterdamumc.nl | |
| Website | http://www.amsterdamumc.nl |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 30/04/2019 | 23/05/2019 | No | Yes | |
| Results article | 21/01/2021 | 13/08/2021 | Yes | No | |
| Protocol file | 28/08/2019 | 05/10/2022 | No | No |
Additional files
- ISRCTN12141624_PIS_30Apr2019.pdf
- Uploaded 23/05/2019
- 36631 protocol 28Aug2019.pdf
Editorial Notes
05/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
13/08/2021: Internal review.
05/07/2021: Publication reference added.
04/09/2020: The intention to publish date was changed from 01/03/2020 to 01/01/2021.
23/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2019 to 04/11/2019.
2. The total final enrolment number was added.
3. The intention to publish date was changed from 01/06/2020 to 01/03/2020.
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
