The pilot study will focus completely on testing of the quality of the CCE procedure as intended in the screening trial. The main study parameters are feasibility and logistical shortcomings, efficacy of bowel preparation and understandability of…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The pilot study will focus completely on testing of the quality of the CCE
procedure as intended in the screening trial. The main study parameters are
feasibility and logistical shortcomings, efficacy of bowel preparation and
understandability of information material.
Secondary outcome
n.a.
Background summary
Colorectal cancer (CRC) is one of the most common malignancies both in men and
women, and accounts for the second cause of cancer-related death in the
Netherlands. The high incidence of the disease, the recognizable precursor, the
long preclinical stage, and the fact that the intensity of treatment and the
risk of death strongly correlate with disease stage all make CRC very suitable
for screening. Long-term randomized prospective trials both based on fecal
occult blood testing (FOBT) as well as sigmoidoscopy showed that screening
indeed reduces CRC-related mortality, and depending on the method also CRC
incidence. Screening programs in other countries as far as implemented by now
are generally based on FOBT screening, while some use sigmoidoscopy or
opportunistic colonoscopy and CT-Colonoscopy screening. The shortcomings of
these approaches are insufficient population coverage, and insufficient yield.
Colon capsule endoscopy (CCE) appears to be a promising new modality for
colonic evaluation. CCE can be the long-expected next generation screening
modality, if a high uptake and diagnostic yield are confirmed in primary
population screening. The results of this pilot study will serve as the basis
for a larger population-based trial to accurately determine the position of CCE
as primary screening tool, as well determination of the required colonoscopy
capacity resulting from primary CCE screening.
Study objective
The pilot study will focus completely on testing of the quality of the CCE
procedure as intended in the screening trial. The main study parameters are
feasibility and logistical shortcomings, efficacy of bowel preparation and
understandability of information material.
Study design
Participants are invited to capsule endoscopy screening using the Pillcam colon
2/2L (Given Imaging ltd. Israel) before colonoscopy.
Intervention
Participants are invited to capsule endoscopy screening using the Pillcam colon
2/2L (Given Imaging ltd. Israel). Colon cleansing consists of a tablet
Bisacodyl 5 mg (Centrafarm BV) at bedtime 2 days before CCE. Subsequently all
participants will start a liquid diet the day before CCE and will receive 2
liter of polyethylene electrolyte glycol solution (Moviprep; Norgine,
Amsterdam, The Netherlands) and 2 liter transparent fluid, split-dose. Booster
during CCE procedure consists of additional 250ml Eziclen boost and an optional
250ml Eziclen boost, each followed by about 0.5 liter of clear liquids. The
second administration is an optional booster, 3 hours after the first booster
which participants will only be instructed to drink in case the capsule has not
already been excreted. After bowel preparation and capsule endoscopy, patients
subsequently will have colonoscopy according to regular procedure.
Participants are asked twice to complete a questionnaire about the expected and
perceived burden; it will take 5-10 minutes to complete one questionnaire.
Study burden and risks
Potential adverse events associated with the use of Pillcam colon 2/2L may
include obstruction or retention of the capsule. Capsule retentions can be
resolved by either laxative ingestion or removal of the capsule during
colonoscopy or in very rare cases surgery.
The procedure involves laxatives and prokinetic agents. See the SPC-texts of
metoclopramide, moviprep or bisacodyl for possible adverse events.
It is made clear that participation is completely voluntary. There are no
individual benefits; participant feedback provides information for improving
the quality of the CCE procedure as intended in the screening trial.
s Gravendijkwal 230
Rotterdam 3015 CE
NL
s Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All consecutive ambulatory patients referred for a colonoscopy at the Gastroenterology and Hepatology Department of the Erasmus MC because of a suspicion of colorectal polyps or colorectal cancer or a positive iFOBT after participation in a FOBT-based CRC screening trial will be eligible for participation.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability or refusal to provide informed consent.
- Persons with a severe or terminal disease with a life-expectancy of less than 5 years.
- An allergy or any other known contraindication to the medication used in the study, including:
- Renal failure, eGFR <60 ml/min/1.73m2
- Congestive heart failure NYHA class III or IV.
- Dysphagia or other swallowing disorder which makes it impossible to swallow the capsule.
- Personal history of gastrointestinal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Cardiac pacemakers or other implanted electro-medical equipment.
- An MRI scheduled within 14 days after ingestion of the capsule.
- Although pregnancy is not likely in this cohort, pregnant women are also excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44021.078.13 |