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

Adenoma Detection Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137277
• Other study ID #: PV4343
• Status: Completed
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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

1. 190 C group (intervention group), examination with the latest generation colonoscope (190 series CF or PCF colonoscopies, Olympus Corp, Hamburg, Germany).

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1221
• Est. completion date: July 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• screening colonoscopy, age = 55 years

• status 1 and 2 of the ASA classification

• signed informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate

Intervention

Procedure:
• screening colonoscopy
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.

Locations

Country	Name	City	State
Germany	Dr. Alireza Aminalai	Berlin
Germany	Dr. Jens Aschenbeck	Berlin
Germany	Gastroenterologie am Bayerischen Platz	Berlin
Germany	Gemeinschaftspraxis Hohenzollerndamm	Berlin
Germany	Praxis Mayr / Heller	Berlin
Germany	Gastroenterologie-Fontanay	Hamburg
Germany	Gastropraxis Eppendorferbaum	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (20)

Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schröder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rösch 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. — View Citation

Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schröder A, Scheel M, Wiedenmann B, Rösch 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. — View Citation

Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rösch 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. Epub 2007 Aug 6. — View Citation

Adler A, Roll S, Marowski B, Drossel R, Rehs HU, Willich SN, Riese J, Wiedenmann B, Rösch 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. — View Citation

Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mroß M, Scheel M, Schröder 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. — View Citation

Bajbouj M, Reichenberger J, Neu B, Prinz C, Schmid RM, Rösch 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. — View Citation

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. — View Citation

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

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. — View Citation

Heldwein W, Dollhopf M, Rösch 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. — View Citation

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. Erratum in: N Engl J Med. 2009 Nov 12;361(20):2004. — View Citation

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. — View Citation

Meining A, Driesnack U, Classen M, Rösch 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. — View Citation

Meining A, Ott R, Becker I, Hahn S, Mühlen J, Werner M, Höfler H, Classen M, Heldwein W, Rösch 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. — View Citation

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. — View Citation

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, Rösch T. Impact of 2 generational im — View Citation

Pohl H, Aschenbeck J, Drossel R, Schröder A, Mayr M, Koch M, Rothe K, Anders M, Voderholzer W, Hoffmann J, Schulz HJ, Liehr RM, Gottschalk U, Wiedenmann B, Rösch 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. — View Citation

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. Epub 2012 Sep 25. — View Citation

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. — View Citation

Zimmermann-Fraedrich K, Groth S, Sehner S, Schubert S, Aschenbeck J, Mayr M, Aminalai A, Schröder A, Bruhn JP, Bläker M, Rösch T, Schachschal G. Effects of two instrument-generation changes on adenoma detection rate during screening colonoscopy: results f — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adenoma rate	Adenoma rate calculated at the adenoma level (all adenomas/all patients) and as the number of adenomas per adenoma carrier.	through study completion, an average of 6 months
Secondary	Adenoma subgroups: size	Adenoma subgroups due to size (< 1 cm, > 1 cm)	through study completion, an average of 6 months
Secondary	Adenoma subgroups: form	Adenoma subgroups due to form (flat, sessile, pedunculated)	through study completion, an average of 6 months
Secondary	Adenoma subgroups: location	Adenoma subgroups due to location (right sided - down to left hepatic flexure, left sided - descending colon, sigmoid and rectum)	through study completion, an average of 6 months
Secondary	Adenoma subgroups: histology	Adenoma subgroups due to histologic subgroups (SSA, HGIN)	through study completion, an average of 6 months
Secondary	Cecal intubation rate	Cecal intubation rate per arm, all patients	through study completion, an average of 6 months
Secondary	complication rate	Complications in both groups	through study completion, an average of 6 months