Colorectal CancerNCT01879943
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
A study testing PillCam Colon 2 and Colonoscopy in people with Colorectal Cancer, run by IHU Strasbourg at 1 site in France.
Trial summary
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery. The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PillCam Colon 2 and Colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2013to 8 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient between 18 and 85 years old
- patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
- patient requiring a colonoscopy for regular medical care
- absence of contra-indication to anesthesia and to colonoscopy conduct
- patient able to understand the study related information and to provide written informed consent
- patient registered with the French social security regime
Show all 19Show fewer
- Non-inclusion Criteria:
- absence of written informed consent
- patient having had a total colectomy
- patient with terminal stoma
- patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis
- patient with known Zenker diverticulum
- patient wearing a pacemaker or any other internal electronic medical device
- patient with deglutition disorders and/or altered state of consciousness
- patient with serious disease preventing planned study procedures
- pregnant or breast-feeding woman
- patient within exclusion period from other clinical trial
- patient having forfeited their freedom of an administrative or legal obligation
- patient being under guardianship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Strasbourg, 67000
About this study
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery.
The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.
Read the detailed description
Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding).
Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the colon as a whole. This technique has the advantage of not requiring general anesthesia or air insufflation. The examination is performed as an outpatient procedure and therefore does not require hospitalization.
In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting colorectal lesions. However, its use requires an excellent bowel preparation.
To date, no study has been conducted using the VCC in monitoring patients with prior colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No information on VCC capabilities to view and recognize surgical anastomoses and VCC transit time in surgically modified colon is available. The possibility to precisely locate a colorectal lesion prior to surgery, using the VCC, also remains to be studied.
The study requires a 2-month patient participation. The planned total study duration is 2 years.
- Conditions
- Colorectal Cancer
- Being tested
- PillCam Colon 2, Colonoscopy
- Keywords
- Colorectal cancer, Follow up, Colonoscopy, Videocapsule
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam Colon 2Device
PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.
ColonoscopyProcedure or surgery
Standard colonoscopy is the standard against which capsule endoscopy is compared.
| Study group | Role | What they receive |
|---|---|---|
| PillCam COLON 2 and Standard Colonoscopy | Experimental | Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.
Interventions:
* Device: PillCam COLON 2 on D0
* Procedure: Standard colonoscopy on D1 Receives: Device: PillCam Colon 2; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with full colonic exploration and detection of lesions
Number of patients for whom the capsule allowed for full colonic exploration and presence/absence of colorectal lesions detected by VCC compared to conventional colonoscopy
Measured: By the end of both procedures (Day 1)
Secondary outcomes (7)
Anastomosis visualization
Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal)
Measured: Prior to colonoscopy on Day 1
Number and size of detected lesions
Number and size of detected lesions with VCC compared to conventional colonoscopy
Measured: By the end of both procedures (Day 1)
Quality of colic preparation
Assessment of the quality of colic preparation for VCC (D0) and colonoscopy (D1)
Measured: By the end of both procedures (Day 1)
Times related to videocapsule
Assessment of times related to videocapsule:
- Transit time of videocapsule : from ingestion to expulsion
- Reading time : time required for reading and analysing videocapsule recordings by gastroenterologist
Measured: Prior to colonoscopy on Day 1
Adverse events related to VCC exam and colonoscopy
Assessment of safety of each method. Recording of adverse events.
Measured: Until end of Day 1
Patient's assessment of tolerability and acceptance
Patient ranking of tolerability and acceptance of each of the procedures using a visual analog scale
Measured: Follow up visit (between Day 15 and Day 30)
Health-economic assessment
Assessment of costs associated to each of the exams:
- Colonoscopy duration (OR entry - exit)
- Device cost (coloscope, capsule)
- Cost of medical exams related to each procedure (from pre-anesthesia to follow-up)
- Cost of medical time related to each procedure
Measured: End of follow-up (between D15 and D30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study start18 Oct 2013
- Primary completion8 Jun 2016
- Study completion8 Jun 2016
Why it stopped: Operational difficulties related to medical staff turnover (investigators departure and sickness leave).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Delvaux, MD, Principal investigator, Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879943
- Sponsor's protocol ID
- 12-003
- Other IDs
- 2012-A01475-38
- Status last verified
- Apr 2019
- First submitted
- 14 Jun 2013
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01879943
- Acronym / sponsor ID
- 12-003
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Follow up, Colonoscopy, Videocapsule
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Operational difficulties related to medical staff turnover (investigators departure and sickness leave).
- Enrolment
- 37 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 8 Jun 2016 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery.
The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.
Detailed description
Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding).
Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the colon as a whole. This technique has the advantage of not requiring general anesthesia or air insufflation. The examination is performed as an outpatient procedure and therefore does not require hospitalization.
In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting colorectal lesions. However, its use requires an excellent bowel preparation.
To date, no study has been conducted using the VCC in monitoring patients with prior colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No information on VCC capabilities to view and recognize surgical anastomoses and VCC transit time in surgically modified colon is available. The possibility to precisely locate a colorectal lesion prior to surgery, using the VCC, also remains to be studied.
The study requires a 2-month patient participation. The planned total study duration is 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillCam COLON 2 and Standard Colonoscopy | Experimental | Device: PillCam Colon 2, Procedure: ColonoscopyPatients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day. Interventions: * Device: PillCam COLON 2 on D0 * Procedure: Standard colonoscopy on D1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- patient between 18 and 85 years old
- patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
- patient requiring a colonoscopy for regular medical care
- absence of contra-indication to anesthesia and to colonoscopy conduct
- patient able to understand the study related information and to provide written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam Colon 2PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps. | Device | PillCam COLON 2 and Standard Colonoscopy |
| ColonoscopyStandard colonoscopy is the standard against which capsule endoscopy is compared. | Procedure or surgery | PillCam COLON 2 and Standard Colonoscopy |
Primary outcome
Number of patients with full colonic exploration and detection of lesions
Time frame: By the end of both procedures (Day 1)
Number of patients for whom the capsule allowed for full colonic exploration and presence/absence of colorectal lesions detected by VCC compared to conventional colonoscopy
7 secondary outcomes
Anastomosis visualization
Time frame: Prior to colonoscopy on Day 1
Number and size of detected lesions
Time frame: By the end of both procedures (Day 1)
Quality of colic preparation
Time frame: By the end of both procedures (Day 1)
Times related to videocapsule
Time frame: Prior to colonoscopy on Day 1
Adverse events related to VCC exam and colonoscopy
Time frame: Until end of Day 1
Patient's assessment of tolerability and acceptance
Time frame: Follow up visit (between Day 15 and Day 30)
Health-economic assessment
Time frame: End of follow-up (between D15 and D30)
Results and safety
The study was stopped early (reason given: Operational difficulties related to medical staff turnover (investigators departure and sickness leave).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Delvaux, MD principal investigator
Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam Colon 2 and Colonoscopy in people with Colorectal Cancer, run by IHU Strasbourg at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Operational difficulties related to medical staff turnover (investigators departure and sickness leave).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with full colonic exploration and detection of lesions (time frame: By the end of both procedures (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.