Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial

Colorectal Cancer Clinical Trial

— ITAvision  

Official title:

Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612674
• Other study ID #: F17G18000000007
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: August 2019

Study information

• Verified date: June 2018
• Source: Cancer Prevention and Research Institute, Italy
• Contact: Grazia Grazzini, MD
• Phone: 003905532697972
• Email: g.grazzini[@]ispro.toscana.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.

Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.

Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.

ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.

Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.

Description:

In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.

It has been demonstrated that screening with fecal occult blood test (FOBT) significantly reduces mortality for CRC. Currently, population-based CRC screening programs using FOBT have been or are heading towards being implemented in many European countries. Fecal immunochemical test (FIT) has been adopted by most Italian Regions as the standard screening test, with total colonoscopy as diagnostic assessment in subjects resulted FIT positive. A significant impact of FIT-based screening on CRC mortality reduction has been observed in an Italian region after 10 years from screening implementation. Moreover, two studies carried out in a Northern-central area of Italy have shown a reduction in CRC incidence in subjects who attended FIT screening programs as compared to non-attendees.

Increasing colonoscopy quality is critical for the screening impact among population. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. ADR is defined as the proportion of colonoscopies during which at least one adenoma can be detected. A polish study showed that ADR was an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. ADR has shown a direct correlation with: operator experience, cecal intubation, quality of bowel preparation, patient sedation, endoscope withdrawal time, presence of flat, depressed or subtle lesions, ability to visualize the proximal side of haustral folds, flexures (blind spots), rectal valves, and ileocecal valves.

On the other hand, colonoscopy is considered the gold standard for adenoma detection, but it has shown some limits. Data from colonoscopy studies showed that up to 25% of polyps were missed during colonoscopy and up to 8% of CRCs occurred within 3 years after a previous colonoscopy. Moreover, recent studies have shown that cancers post-colonoscopy are most likely due to missed lesions, rather than being new lesions.

For these reasons, industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.

ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.

Previous researches have studied the performance of colonoscope distal attachment devices. More specifically, a 2016 meta-analysis of more than 5,000 patients demonstrates that, compared to traditional colonoscopy, the use of an Endocuff device improves ADR without any adverse effect on procedural efficiency or increased risk of significant adverse events. Moreover, Facciorusso et al. in 2017 assessed only a modest improvement in ADR by using distal attachment devices, especially in low-performing endoscopists, while in 2018 Williet showed, with moderate-quality evidence, an improvement in ADR with EAC without major adverse events, especially for operators with low-to-moderate ADR.

Second-generation AEV is a soft plastic cap, to be applied on the top of the colonoscopy. The cap has a propylene-made cylindrical core, with a single row of flexible arms. During the colon intubation procedure the device is nearly invisible, while in the retraction phase the arms begin to work, opening up and pulling the colon walls, stretching convoluted tracts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: August 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• Subject with a positive FIT result in the frame of national screening program

Exclusion Criteria:

• Subjects younger than 50 years old

• Active Inflammatory Bowel Disease

• Known condition of cholic stenosis

• Acute diverticulitis

• Patient not able to sign a informed consent form

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp

Intervention

Procedure:
• Standard colonoscopy
Current standard of care colonoscopy.

Device:
• ARC Endocuff Vision
Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.

Locations

Country	Name	City	State
Italy	Cazzavillan Hospital, Local Health Unit 8 Berica, Veneto Region	Arzignano	Vicenza
Italy	San Martino Hospital, Local Health Unit 1 Dolomiti, Veneto Region	Belluno	BL
Italy	Maggiore Hospital, Crema Territorial Health Care Company, Lombardia Region	Crema	Cremona
Italy	Santa Maria del Prato, Local Health Unit 1 Dolomiti, Veneto Region	Feltre	Belluno
Italy	Screening Unit, Oncological Network, Prevention and Research Institute	Florence
Italy	San Paolo Hospital Company - University Campus	Milan
Italy	Sant'Antonio Hospital, Local Health Unit 6 Euganea, Veneto Region	Padova
Italy	Veneto Tumor Registry, Local Health Unit 4, Veneto Region	Padova
Italy	Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region	Rovigo
Italy	Ca' Foncello Hospital, Local Health Unit 2 Marca Trevigiana, Veneto Region	Treviso
Italy	Molinette Hospital, Città della Salute e della Scienza University Hospital Company	Turin
Italy	San Bonifacio Hospital, Local Health Unit 9 Scaligera, Veneto Region	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Prevention and Research Institute, Italy	Veneto Tumor Registry, Azienda Zero, Padua, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (16)

Chin M, Karnes W, Jamal MM, Lee JG, Lee R, Samarasena J, Bechtold ML, Nguyen DL. Use of the Endocuff during routine colonoscopy examination improves adenoma detection: A meta-analysis. World J Gastroenterol. 2016 Nov 21;22(43):9642-9649. Review. — View Citation

Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. — View Citation

Facciorusso A, Del Prete V, Buccino RV, Della Valle N, Nacchiero MC, Monica F, Cannizzaro R, Muscatiello N. Comparative Efficacy of Colonoscope Distal Attachment Devices in Increasing Rates of Adenoma Detection: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1209-1219.e9. doi: 10.1016/j.cgh.2017.11.007. Epub 2017 Nov 11. Review. — View Citation

Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15. Review. — View Citation

Giorgi Rossi P, Vicentini M, Sacchettini C, Di Felice E, Caroli S, Ferrari F, Mangone L, Pezzarossi A, Roncaglia F, Campari C, Sassatelli R, Sacchero R, Sereni G, Paterlini L, Zappa M. Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Am J Gastroenterol. 2015 Sep;110(9):1359-66. doi: 10.1038/ajg.2015.240. Epub 2015 Aug 25. — 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

le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6. — View Citation

Leufkens AM, van Oijen MG, Vleggaar FP, Siersema PD. Factors influencing the miss rate of polyps in a back-to-back colonoscopy study. Endoscopy. 2012 May;44(5):470-5. doi: 10.1055/s-0031-1291666. Epub 2012 Mar 22. — View Citation

Munroe CA, Lee P, Copland A, Wu KK, Kaltenbach T, Soetikno RM, Friedland S. A tandem colonoscopy study of adenoma miss rates during endoscopic training: a venture into uncharted territory. Gastrointest Endosc. 2012 Mar;75(3):561-7. doi: 10.1016/j.gie.2011.11.037. — View Citation

Pohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010 Oct;8(10):858-64. doi: 10.1016/j.cgh.2010.06.028. Epub 2010 Jul 22. — View Citation

Pullens HJ, Siersema PD. Quality indicators for colonoscopy: Current insights and caveats. World J Gastrointest Endosc. 2014 Dec 16;6(12):571-83. doi: 10.4253/wjge.v6.i12.571. Review. — View Citation

Rees CJ, Rajasekhar PT, Rutter MD, Dekker E. Quality in colonoscopy: European perspectives and practice. Expert Rev Gastroenterol Hepatol. 2014 Jan;8(1):29-47. doi: 10.1586/17474124.2014.858599. Epub 2013 Dec 2. Review. — View Citation

Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. — View Citation

van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. Review. — View Citation

Williet N, Tournier Q, Vernet C, Dumas O, Rinaldi L, Roblin X, Phelip JM, Pioche M. Effect of Endocuff-assisted colonoscopy on adenoma detection rate: meta-analysis of randomized controlled trials. Endoscopy. 2018 Apr 26. doi: 10.1055/a-0577-3500. [Epub ahead of print] — View Citation

Zorzi M, Senore C, Da Re F, Barca A, Bonelli LA, Cannizzaro R, Fasoli R, Di Furia L, Di Giulio E, Mantellini P, Naldoni C, Sassatelli R, Rex D, Hassan C, Zappa M; Equipe Working Group. Quality of colonoscopy in an organised colorectal cancer screening programme with immunochemical faecal occult blood test: the EQuIPE study (Evaluating Quality Indicators of the Performance of Endoscopy). Gut. 2015 Sep;64(9):1389-96. doi: 10.1136/gutjnl-2014-307954. Epub 2014 Sep 16. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma Detection Rate (ADR)	Comparison of the number of adenomas (ADR) detected per subject between the Endocuff Vision colonoscopy and the standard colonoscopy.	Through study completion, an average of 1 year
Secondary	Patient values	Comparison of ADR according to patient's age, sex, screening history (first or subsequent test) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.	Day 1
Secondary	Exam values	Comparison of cecum intubation, patient discomfort (with Visual Analogue Scale -VAS) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.; The Visual Analogue Scale goes from 1 to 10, where 1 is the absence pain and 10 is severe pain.; Number 1 represents the best outcome measure, while 10 is the worst result for this outcome measure.	Day 1
Secondary	Number of lesions	Comparison of polyps number between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.	Day 1
Secondary	Size	Comparison of polyps size between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.	Day 1
Secondary	Anatomical site	Comparison of polyps anatomical site between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.	Day 1
Secondary	Histological diagnoses	Comparison of polyps histological diagnoses between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.	Through study completion, an average of 1 year
Secondary	Colonoscopist' age	Analysis of the involved colonoscopists' age.	Through study completion, an average of 1 year
Secondary	Colonoscopist' years of experience	Analysis of the involved colonoscopists' years of experience.	Through study completion, an average of 1 year
Secondary	Colonoscopist' specialization	Analysis of the involved colonoscopists' specialization.	Through study completion, an average of 1 year
Secondary	Colonoscopist' number of exams in the previous year	Analysis of the involved colonoscopists' number of exams in the previous year.	Through study completion, an average of 1 year
Secondary	Colonoscopists' ADR in the previous year	Analysis of the involved colonoscopists' ADR in the previous year.	Through study completion, an average of 1 year