Condition category
Cancer
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Evelien Dekker

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Gastroenterology and Hepatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3632
E.Dekker@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR521

Study information

Scientific title

Acronym

POLPAN study

Study hypothesis

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

Received from the Medisch Ethische Commissie (Medical Ethical
Commitee) Academisch Medisch Centrum (AMC) on the 9th June 2005 (ref: MEC05/097 #05.17.0799).

Study design

Randomised, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer, polyps

Intervention

High resolution white light endoscopy versus autofluorescence endoscopy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The sensitivity of high resolution white light endoscopy will be compared to that of AFI for detection of polyps and cancer in the colon.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2005

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Familiar adenomatous polyposis
2. History of inflammatory bowel disease
3. Severe coagulopathy
4. Age less than 18 years

Recruitment start date

01/06/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes