A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy

NCT03137277 | Completed

• 1 other identifier: PV4343
• Study Type: observational
• Target: 1,221
• Locations: 1 country
• Sites: 7

Brief 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 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).

Conditions

Adenoma Detection Rate

Keywords

Colonoscopy; ADR; Adenoma detection rate; colonoscopic imaging feature improvement; Olympus colonoscopes

Outcome Measures

Primary Outcomes (1)

• 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).

  day 1

Secondary Outcomes (7)

• Adenoma rate

  through study completion, an average of 6 months

• Adenoma subgroups: size

  through study completion, an average of 6 months

• Adenoma subgroups: form

  through study completion, an average of 6 months

• Adenoma subgroups: location

  through study completion, an average of 6 months

• Adenoma subgroups: histology

  through study completion, an average of 6 months

Study Arms (2)

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).

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),

Procedure: screening colonoscopy

Interventions

screening colonoscopy PROCEDURE

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.

Olympus 160/165; Olympus 190

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 55 years and above, planned for a screening colonoscopy in one of the parttaking private practices.

You may qualify if:

• screening colonoscopy, age ≥ 55 years
• status 1 and 2 of the ASA classification
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (7)

Gemeinschaftspraxis Hohenzollerndamm

Berlin, 10713, Germany

Location

Gastroenterologie am Bayerischen Platz

Berlin, 10825, Germany

Location

Praxis Mayr / Heller

Berlin, 12163, Germany

Location

Dr. Alireza Aminalai

Berlin, 13437, Germany

Location

Dr. Jens Aschenbeck

Berlin, 13581, Germany

Location

Gastropraxis Eppendorferbaum

Hamburg, 20246, Germany

Location

Gastroenterologie-Fontanay

Hamburg, 20354, Germany

Location

Related Publications (20)

• 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.

  PMID: 18799558 BACKGROUND

• Winawer 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.

  PMID: 8531963 BACKGROUND

• von 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.

  PMID: 23012113 BACKGROUND

• Millan 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.

  PMID: 18500502 BACKGROUND

• Bretagne 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.

  PMID: 18464196 BACKGROUND

• Kaminski 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.

  PMID: 20463339 BACKGROUND

• Barclay 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.

  PMID: 17167136 BACKGROUND

• Bock, J., Toutenburg, H. (1991). Sample size determination in clinical research. In: Rao, C.R., Chakraborty, R. (eds.): Handbook of statistics, Elsevier, 515 - 538.

  BACKGROUND

• 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.

  PMID: 22442161 BACKGROUND

• Adler 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.

  PMID: 22056301 BACKGROUND

• Adler 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.

  PMID: 19014944 BACKGROUND

• Adler 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.

  PMID: 17681999 BACKGROUND

• Adler 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.

  PMID: 17694415 BACKGROUND

• Pohl 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.

  PMID: 18482289 BACKGROUND

• Meining 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.

  PMID: 15361485 BACKGROUND

• Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.

  PMID: 16281142 BACKGROUND

• Meining A, Driesnack U, Classen M, Rosch T. Management of gastroesophageal reflux disease in primary care: results of a survey in 2 areas in Germany. Z Gastroenterol. 2002 Jan;40(1):15-20. doi: 10.1055/s-2002-19638.

  PMID: 11803496 BACKGROUND

• Bajbouj M, Reichenberger J, Neu B, Prinz C, Schmid RM, Rosch T, Meining A. A prospective multicenter clinical and endoscopic follow-up study of patients with gastroesophageal reflux disease. Z Gastroenterol. 2005 Dec;43(12):1303-7. doi: 10.1055/s-2005-858874.

  PMID: 16315125 BACKGROUND

• Pioche M, Denis A, Allescher HD, Andrisani G, Costamagna G, Dekker E, Fockens P, Gerges C, Groth S, Kandler J, Lienhart I, Neuhaus H, Petruzziello L, Schachschal G, Tytgat K, Wallner J, Weingart V, Touzet S, Ponchon T, Rosch T. Impact of 2 generational improvements in colonoscopes on adenoma miss rates: results of a prospective randomized multicenter tandem study. Gastrointest Endosc. 2018 Jul;88(1):107-116. doi: 10.1016/j.gie.2018.01.025. Epub 2018 Feb 4.

  PMID: 29410020 RESULT

• Zimmermann-Fraedrich K, Groth S, Sehner S, Schubert S, Aschenbeck J, Mayr M, Aminalai A, Schroder A, Bruhn JP, Blaker M, Rosch T, Schachschal G. Effects of two instrument-generation changes on adenoma detection rate during screening colonoscopy: results from a prospective randomized comparative study. Endoscopy. 2018 Sep;50(9):878-885. doi: 10.1055/a-0607-2636. Epub 2018 Jul 23.

  PMID: 30036893 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon Polyps and Adenoma

Study Officials

• Thomas Rösch, Prof. Dr.

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Director of Interdisciplinary Endoscopy Department and Clinic

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 2, 2017
• Study Start: November 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: July 1, 2017
• Last Updated: June 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)