Adenoma Detection RateNCT03137277
A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
An observational study of Adenoma Detection Rate, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in Germany.
Trial summary
Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of (screening) colonoscopy. Since single improvements of imaging have not been able to improve ADR in many randomized studies, the present study tested the hypothesis that only multiple imaging improvements such as seen with two… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Adenoma Detection Rate
- What is being tested?
- screening colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,221 participants
- Where
- 7 sitesGermany
- Study dates
- Nov 2013to Jul 2017
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 55 years and above, planned for a screening colonoscopy in one of the parttaking private practices.
Who may be able to join
- screening colonoscopy, age ≥ 55 years
- status 1 and 2 of the ASA classification
- signed informed consent
Who cannot join
- Symptoms indicative of colorectal disease such as colonic bleeding, significant diarrhea, obstipation and change in bowel habits
- Known colonic disease for further evaluation (e.g. inflammatory bowel disease, polyps for resection)
- Surveillance after polypectomy or colon tumor surgery
- Anticoagulants preventing biopsy or polypectomy
- Poor general condition (ASA III or more)
- Incomplete colonoscopy planned
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Gemeinschaftspraxis Hohenzollerndamm
Berlin, 10713
Gastroenterologie am Bayerischen Platz
Berlin, 10825
Praxis Mayr / Heller
Berlin, 12163
Dr. Alireza Aminalai
Berlin, 13437
Dr. Jens Aschenbeck
Berlin, 13581
Gastropraxis Eppendorferbaum
Hamburg, 20246
Gastroenterologie-Fontanay
Hamburg, 20354
About this study
Official title: A Randomized Comparative Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of (screening) colonoscopy. Since single improvements of imaging have not been able to improve ADR in many randomized studies, the present study tested the hypothesis that only multiple imaging improvements such as seen with two generation changes of colonoscopies - i.e. skipping one colonoscope generation - may be necessary before improvements in ADR can be measured.
The investigators will test this hypothesis in the present randomized tandem study in 7 private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at inclusion of 1200 patients > age of 55 years (screening colonoscopy cut-off in Germany). Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all patients).
Read the detailed description
The study was a prospective multicenter randomized study involving 7 private practice gastroenterology offices with a total of 14 experienced examiners (> 2000 colonoscopies), performed between November 2013 and September 2016 (sets of instruments were made available to 3-4 centers each during 6-12 months).Study population:
Patients were selected from the screening colonoscopy list (age ≥ 55 years), with further inclusion criteria being status 1 and 2 of the ASA classification. After informed consent, patients were randomized using sealed envelopes per center to one of either of the two study groups
- 190 C group (intervention group), examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
- 165 C group (control group), examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), Each patient underwent bowel preparation in accordance with local practice of the centers. Bowel cleansing quality was segmentally assessed using a modified overall "Boston Bowel Preparation Scale". Introduction and withdrawal times were measured, and times required for biopsies and polypectomies were considered separately, i.e. overall and diagnostic only withdrawal times were recorded separately.
Polyps were documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous). Polyps were then resected using biopsy forceps or cold snare or conventional polypectomy according to local standards. Histology of resected polyps was analyzed by local private practice specialized GI pathologists according to the Vienna classification with regards to dysplasia grade and the presence of serrated adenomas; final histologic categories were hyperplastic, adenomatous [tubulous, villous, tubulovillous, serrated (traditional or sessile serrated)]. Small distal rectal polyps were not systematically biopsied or resected, due to a very high likelihood to be hyperplastic.
- Conditions
- Adenoma Detection Rate
- Being tested
- screening colonoscopy
- Keywords
- Colonoscopy, ADR, Adenoma detection rate, colonoscopic imaging feature improvement, Olympus colonoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening colonoscopyProcedure or surgery
Introduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately.
Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps < 5 mm), or conventional polypectomy according to local standards.
| Study group | Role | What they receive |
|---|---|---|
| Olympus 190 | Olympus colonoscope 190 C (intervention group), screening colonoscopy examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany). Receives: Procedure: screening colonoscopy | |
| Olympus 160/165 | Olympus colonoscope 165 C (control group), screening colonoscopy examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), Receives: Procedure: screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
adenoma detection rate (ADR) of 190 colonoscopes in comparison to 160/5 colonoscopes at the patient level (% of patients with at least one adenoma).
Measured: day 1
Secondary outcomes (7)
Adenoma rate
Adenoma rate calculated at the adenoma level (all adenomas/all patients) and as the number of adenomas per adenoma carrier.
Measured: through study completion, an average of 6 months
Adenoma subgroups: size
Adenoma subgroups due to size (< 1 cm, > 1 cm)
Measured: through study completion, an average of 6 months
Adenoma subgroups: form
Adenoma subgroups due to form (flat, sessile, pedunculated)
Measured: through study completion, an average of 6 months
Adenoma subgroups: location
Adenoma subgroups due to location (right sided - down to left hepatic flexure, left sided - descending colon, sigmoid and rectum)
Measured: through study completion, an average of 6 months
Adenoma subgroups: histology
Adenoma subgroups due to histologic subgroups (SSA, HGIN)
Measured: through study completion, an average of 6 months
Cecal intubation rate
Cecal intubation rate per arm, all patients
Measured: through study completion, an average of 6 months
complication rate
Complications in both groups
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startNov 2013
- Primary completionSep 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Adenoma Detection RateStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. Dr., Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137277
- Sponsor's protocol ID
- PV4343
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data sharing
Publications
Imperiale TF, Glowinski EA, Lin-Cooper C, Larkin GN, Rogge JD, Ransohoff DF. Five-year risk of colorectal neoplasia after negative screening colonoscopy. N Engl J Med. 2008 Sep 18;359(12):1218-24. doi: 10.1056/NEJMoa0803597.
PubMed 18799558Winawer SJ, Zauber AG, Gerdes H, O'Brien MJ, Gottlieb LS, Sternberg SS, Bond JH, Waye JD, Schapiro M, Panish JF, et al. Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup. N Engl J Med. 1996 Jan 11;334(2):82-7. doi: 10.1056/NEJM199601113340204.
PubMed 8531963von Karsa L, Patnick J, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Executive summary. Endoscopy. 2012 Sep;44 Suppl 3:SE1-8. doi: 10.1055/s-0032-1309822. Epub 2012 Sep 25.
PubMed 23012113Millan MS, Gross P, Manilich E, Church JM. Adenoma detection rate: the real indicator of quality in colonoscopy. Dis Colon Rectum. 2008 Aug;51(8):1217-20. doi: 10.1007/s10350-008-9315-3. Epub 2008 May 24.
PubMed 18500502Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.
PubMed 18464196Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
PubMed 20463339Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
PubMed 17167136Bock, J., Toutenburg, H. (1991). Sample size determination in clinical research. In: Rao, C.R., Chakraborty, R. (eds.): Handbook of statistics, Elsevier, 515 - 538.
Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
PubMed 22442161Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
PubMed 22056301Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
PubMed 19014944Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
PubMed 17681999Adler A, Roll S, Marowski B, Drossel R, Rehs HU, Willich SN, Riese J, Wiedenmann B, Rosch T; Berlin Private-Practice Gastroenterology Working Group. Appropriateness of colonoscopy in the era of colorectal cancer screening: a prospective, multicenter study in a private-practice setting (Berlin Colonoscopy Project 1, BECOP 1). Dis Colon Rectum. 2007 Oct;50(10):1628-38. doi: 10.1007/s10350-007-9029-y.
PubMed 17694415Pohl H, Aschenbeck J, Drossel R, Schroder A, Mayr M, Koch M, Rothe K, Anders M, Voderholzer W, Hoffmann J, Schulz HJ, Liehr RM, Gottschalk U, Wiedenmann B, Rosch T. Endoscopy in Barrett's oesophagus: adherence to standards and neoplasia detection in the community practice versus hospital setting. J Intern Med. 2008 Oct;264(4):370-8. doi: 10.1111/j.1365-2796.2008.01977.x. Epub 2008 May 15.
PubMed 18482289Meining A, Ott R, Becker I, Hahn S, Muhlen J, Werner M, Hofler H, Classen M, Heldwein W, Rosch T. The Munich Barrett follow up study: suspicion of Barrett's oesophagus based on either endoscopy or histology only--what is the clinical significance? Gut. 2004 Oct;53(10):1402-7. doi: 10.1136/gut.2003.036822.
PubMed 15361485
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT03137277
- Acronym / sponsor ID
- PV4343
- Conditions
- Adenoma Detection Rate
- Keywords
- Colonoscopy, ADR, Adenoma detection rate, colonoscopic imaging feature improvement, Olympus colonoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,221 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
Adenoma detection rate (ADR) is the most important parameter to measure outcome quality of (screening) colonoscopy. Since single improvements of imaging have not been able to improve ADR in many randomized studies, the present study tested the hypothesis that only multiple imaging improvements such as seen with two generation changes of colonoscopies - i.e. skipping one colonoscope generation - may be necessary before improvements in ADR can be measured.
The investigators will test this hypothesis in the present randomized tandem study in 7 private practices in Hamburg and Berlin, in a pure screening colonoscopy setting, aiming at inclusion of 1200 patients > age of 55 years (screening colonoscopy cut-off in Germany). Exclusion criteria are symptomatic patients and colonoscopies planned for therapeutic reasons. Main outcome parameter is the ADR (rate of patients with at least one adenoma/all patients).
Detailed description
The study was a prospective multicenter randomized study involving 7 private practice gastroenterology offices with a total of 14 experienced examiners (> 2000 colonoscopies), performed between November 2013 and September 2016 (sets of instruments were made available to 3-4 centers each during 6-12 months).Study population:
Patients were selected from the screening colonoscopy list (age ≥ 55 years), with further inclusion criteria being status 1 and 2 of the ASA classification. After informed consent, patients were randomized using sealed envelopes per center to one of either of the two study groups
- 190 C group (intervention group), examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).
- 165 C group (control group), examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), Each patient underwent bowel preparation in accordance with local practice of the centers. Bowel cleansing quality was segmentally assessed using a modified overall "Boston Bowel Preparation Scale". Introduction and withdrawal times were measured, and times required for biopsies and polypectomies were considered separately, i.e. overall and diagnostic only withdrawal times were recorded separately.
Polyps were documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous). Polyps were then resected using biopsy forceps or cold snare or conventional polypectomy according to local standards. Histology of resected polyps was analyzed by local private practice specialized GI pathologists according to the Vienna classification with regards to dysplasia grade and the presence of serrated adenomas; final histologic categories were hyperplastic, adenomatous [tubulous, villous, tubulovillous, serrated (traditional or sessile serrated)]. Small distal rectal polyps were not systematically biopsied or resected, due to a very high likelihood to be hyperplastic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olympus 190 | – | Procedure: screening colonoscopyOlympus colonoscope 190 C (intervention group), screening colonoscopy examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany). |
| Olympus 160/165 | – | Procedure: screening colonoscopyOlympus colonoscope 165 C (control group), screening colonoscopy examination with the 160/5 generation colonoscope (Olympus Corp, Hamburg, Germany), |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 55 years and above, planned for a screening colonoscopy in one of the parttaking private practices.
Key inclusion criteria (3 listed)
- screening colonoscopy, age ≥ 55 years
- status 1 and 2 of the ASA classification
- signed informed consent
Key exclusion criteria (6 listed)
- Symptoms indicative of colorectal disease such as colonic bleeding, significant diarrhea, obstipation and change in bowel habits
- Known colonic disease for further evaluation (e.g. inflammatory bowel disease, polyps for resection)
- Surveillance after polypectomy or colon tumor surgery
- Anticoagulants preventing biopsy or polypectomy
- Poor general condition (ASA III or more)
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 |
|---|---|---|
| screening colonoscopyIntroduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately. Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps < 5 mm), or conventional polypectomy according to local standards. | Procedure or surgery | Olympus 160/165, Olympus 190 |
Primary outcome
Adenoma detection rate
Time frame: day 1
adenoma detection rate (ADR) of 190 colonoscopes in comparison to 160/5 colonoscopes at the patient level (% of patients with at least one adenoma).
7 secondary outcomes
Adenoma rate
Time frame: through study completion, an average of 6 months
Adenoma subgroups: size
Time frame: through study completion, an average of 6 months
Adenoma subgroups: form
Time frame: through study completion, an average of 6 months
Adenoma subgroups: location
Time frame: through study completion, an average of 6 months
Adenoma subgroups: histology
Time frame: through study completion, an average of 6 months
Cecal intubation rate
Time frame: through study completion, an average of 6 months
complication rate
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 18799558Imperiale TF, Glowinski EA, Lin-Cooper C, Larkin GN, Rogge JD, Ransohoff DF. Five-year risk of colorectal neoplasia after negative screening colonoscopy. N Engl J Med. 2008 Sep 18;359(12):1218-24. doi: 10.1056/NEJMoa0803597.
- Background: PubMed 8531963Winawer SJ, Zauber AG, Gerdes H, O'Brien MJ, Gottlieb LS, Sternberg SS, Bond JH, Waye JD, Schapiro M, Panish JF, et al. Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup. N Engl J Med. 1996 Jan 11;334(2):82-7. doi: 10.1056/NEJM199601113340204.
- Background: PubMed 23012113von Karsa L, Patnick J, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Executive summary. Endoscopy. 2012 Sep;44 Suppl 3:SE1-8. doi: 10.1055/s-0032-1309822. Epub 2012 Sep 25.
- Background: PubMed 18500502Millan MS, Gross P, Manilich E, Church JM. Adenoma detection rate: the real indicator of quality in colonoscopy. Dis Colon Rectum. 2008 Aug;51(8):1217-20. doi: 10.1007/s10350-008-9315-3. Epub 2008 May 24.
- Background: PubMed 18464196Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.
- Background: PubMed 20463339Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
- Background: PubMed 17167136Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
- BackgroundBock, J., Toutenburg, H. (1991). Sample size determination in clinical research. In: Rao, C.R., Chakraborty, R. (eds.): Handbook of statistics, Elsevier, 515 - 538.
- Background: PubMed 22442161Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
- Background: PubMed 22056301Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
- Background: PubMed 19014944Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
- Background: PubMed 17681999Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
- Individual participant dataSharing planned: No. no individual participant data sharing
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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.
Thomas Rösch, Prof. Dr. principal investigator
University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma Detection Rate, run by Universitätsklinikum Hamburg-Eppendorf at 7 sites in Germany.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adenoma detection rate (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137277, which also lists 20 linked publications.
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 7 Jun 2019.