Video autofluorescence imaging for detection of adenomatous POLyps of the colon in intermediate and high-risk PAtieNts

ISRCTN	ISRCTN76121851
DOI	https://doi.org/10.1186/ISRCTN76121851
Protocol serial number	NTR521
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Evelien Dekker
Scientific

Academic Medical Centre (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 3632
Email	E.Dekker@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Video autofluorescence imaging for detection of adenomatous POLyps of the colon in intermediate and high-risk PAtieNts
Study acronym	POLPAN study
Study objectives	The aims of the study are: 1. To assess the clinical utility and feasibility of autofluorescence imaging (AFI) surveillance colonoscopy in patients with intermediate or high risk for adenomatous polyps 2. To determine the additional value of AFI in the detection of polyps in these patients 3. To characterise the pit-patterns in the different polyps using narrow band imaging (NBI)
Ethics approval(s)	Received from the Medisch Ethische Commissie (Medical Ethical Commitee) Academisch Medisch Centrum (AMC) on the 9th June 2005 (ref: MEC05/097 #05.17.0799).
Health condition(s) or problem(s) studied	Cancer, polyps
Intervention	High resolution white light endoscopy versus autofluorescence endoscopy.
Intervention type	Other
Primary outcome measure(s)	The sensitivity of high resolution white light endoscopy will be compared to that of AFI for detection of polyps and cancer in the colon.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Total final enrolment	100
Key inclusion criteria	1. Previous adenomatous polyp (polyp-surveillance) 2. Previous adenocarcinoma of the colon for which a partial colectomy was performed 3. Hereditary non-polyposis colorectal cancer (either genetically proven by a mutation in one of the mismatch repair genes or with a clinical diagnosis according to the Amsterdam II criteria) 4. Positive family history for colorectal cancer (CRC): a first-degree family-member fulfills one of the revised Bethesda criteria
Key exclusion criteria	1. Familiar adenomatous polyposis 2. History of inflammatory bowel disease 3. Severe coagulopathy 4. Age less than 18 years
Date of first enrolment	01/06/2005
Date of final enrolment	01/12/2006

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009	06/01/2021	Yes	No

06/01/2021: Publication reference and total final enrolment added.