Chromoendoscopy for Serrated Polyposis Syndrome

NCT03476434 | Completed

• 1 other identifier: HUMostoles 29115
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Serrated polyposis syndrome (SPS) is the most common colorectal polyposis syndrome and is characterized by the combination of large and/or numerous serrated lesions (SLs) throughout the colorectum. SLs are classified into sessile serrated polyps (SSP) with or without dysplasia, hyperplastic polyps (HP) and traditional serrated adenomas (TSA). In 2010 the World Health Organization (WHO) defined this syndrome by any one of the following conditions: criterion I, at least 5 SLs proximal to the sigmoid colon with 2 or more of these being \>10mm in size; criterion II, any SLs proximal to the sigmoid colon in a first-degree relative with SPS; criterion III, more than 20 SLs of any size distributed throughout the colon. It has been demonstrated that 11.8-28.5% of patients with SPS present with colorectal cancer (CRC) at diagnosis. Tandem colonoscopy studies have demonstrated that a significant number of lesions are missed during conventional colonoscopy. This finding is even more evident when focusing SLs where a 31% miss rate has been reported. SLs are often overlooked due to their typical appearance: flat morphology, similar colour to the surrounding mucosa, subtle and indistinctive borders. Chromoendoscopy (dye spraying onto the surface of the colon) enhances the detection of subtle and flat polyps in the colon. Until the date no studies have assessed the use of dye-based chromoendoscopy in SPS patients. The aim of this trial was to evaluate the usefulness of panchromoendoscopy with indigo carmine for the detection of polyps in the colon in patients with SPS. Secondary aims were to estimate the SLs and adenoma miss rates in these patients. Patients were randomized in a 1:1 distribution to one of the two arms of the study by a list of random numbers distributed by the coordinator center. After randomization, patients were submitted to tandem colonoscopies by the same endoscopist:

• In group A (HR-WLE) the first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE.
• In group B (HR-CE) the first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy. For this, the lumen was sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air. After allowing a few seconds for the dye to settle onto the mucosal surface, excess pools of indigo carmine were suctioned and the mucosa was then scrutinised. Time to withdrawal from the cecum was measured using a stopwatch excluding time needed for polypectomy and biopsies. Lesions detected during each inspection were described and then removed. Size (measured in comparison with an open biopsy forceps), morphology (using the Paris classification), location and polypectomy technique were recorded before removal. Histology was used as gold standard.

Conditions

Colonic Polyp; Colonic Neoplasms; Colonic Cancer

Keywords

sessile serrated polyp; chromoendoscopy; indigo carmine

Outcome Measures

Primary Outcomes (1)

• polyp miss rate

  number of polyps detected during the second inspection divided by the total number of polyps detected during the first and the second examination

  through study completion, an average of 2 years

Secondary Outcomes (2)

• serrated lesions miss rate

  through study completion, an average of 2 year

• adenoma miss rate

  through study completion, an average of 2 year

Study Arms (2)

group A (HR-WLE)

NO INTERVENTION

Two tandem colonoscopies: first inspection was on high-resolution white-light endoscopy from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection also on HR-WLE.

group B (HR_CE)

EXPERIMENTAL

two tandem colonoscopies: first inspection was on HR-WLE from the cecum/ileo-colonic anastomosis to the rectum, followed by a second inspection with panchromoendoscopy on indigo carmine.

Device: chromoendoscopy with indigo carmine

Interventions

chromoendoscopy with indigo carmine DEVICE

the lumen of the colon is sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air.

group B (HR_CE)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Serrated Polyposis Syndrome aged 18 years or older, fulfilling WHO criteria I or III.
• Clearing of all polyps previously achieved. Polyp "clearing" considered when all polyps \>3 mm were removed during previous colonoscopies and/or partial colonic surgery when needed.
• Surveillance colonoscopy.

You may not qualify if:

• Inflammatory bowel disease.
• Hereditary CRC syndromes (i.e, APC, MUTYH - biallelic - and MMR genes germline mutations).
• Total colectomy.
• Decline for participation.

Sponsors & Collaborators

• Hospital Universitario de Móstoles: lead

Related Publications (10)

• Rubio CA, Stemme S, Jaramillo E, Lindblom A. Hyperplastic polyposis coli syndrome and colorectal carcinoma. Endoscopy. 2006 Mar;38(3):266-70. doi: 10.1055/s-2006-925026.

  PMID: 16528654 BACKGROUND

• East JE, Saunders BP, Jass JR. Sporadic and syndromic hyperplastic polyps and serrated adenomas of the colon: classification, molecular genetics, natural history, and clinical management. Gastroenterol Clin North Am. 2008 Mar;37(1):25-46, v. doi: 10.1016/j.gtc.2007.12.014.

  PMID: 18313538 BACKGROUND

• Gao Q, Tsoi KK, Hirai HW, Wong MC, Chan FK, Wu JC, Lau JY, Sung JJ, Ng SC. Serrated polyps and the risk of synchronous colorectal advanced neoplasia: a systematic review and meta-analysis. Am J Gastroenterol. 2015 Apr;110(4):501-9; quiz 510. doi: 10.1038/ajg.2015.49. Epub 2015 Mar 10.

  PMID: 25756237 BACKGROUND

• Boparai KS, Mathus-Vliegen EM, Koornstra JJ, Nagengast FM, van Leerdam M, van Noesel CJ, Houben M, Cats A, van Hest LP, Fockens P, Dekker E. Increased colorectal cancer risk during follow-up in patients with hyperplastic polyposis syndrome: a multicentre cohort study. Gut. 2010 Aug;59(8):1094-100. doi: 10.1136/gut.2009.185884. Epub 2009 Aug 25.

  PMID: 19710031 RESULT

• Carballal S, Rodriguez-Alcalde D, Moreira L, Hernandez L, Rodriguez L, Rodriguez-Moranta F, Gonzalo V, Bujanda L, Bessa X, Poves C, Cubiella J, Castro I, Gonzalez M, Moya E, Oquinena S, Clofent J, Quintero E, Esteban P, Pinol V, Fernandez FJ, Jover R, Cid L, Lopez-Ceron M, Cuatrecasas M, Lopez-Vicente J, Leoz ML, Rivero-Sanchez L, Castells A, Pellise M, Balaguer F; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. Colorectal cancer risk factors in patients with serrated polyposis syndrome: a large multicentre study. Gut. 2016 Nov;65(11):1829-1837. doi: 10.1136/gutjnl-2015-309647. Epub 2015 Aug 11.

  PMID: 26264224 RESULT

• Hazewinkel Y, Lopez-Ceron M, East JE, Rastogi A, Pellise M, Nakajima T, van Eeden S, Tytgat KM, Fockens P, Dekker E. Endoscopic features of sessile serrated adenomas: validation by international experts using high-resolution white-light endoscopy and narrow-band imaging. Gastrointest Endosc. 2013 Jun;77(6):916-24. doi: 10.1016/j.gie.2012.12.018. Epub 2013 Feb 21.

  PMID: 23433877 RESULT

• Hazewinkel Y, Tytgat KM, van Leerdam ME, Koornstra JJ, Bastiaansen BA, van Eeden S, Fockens P, Dekker E. Narrow-band imaging for the detection of polyps in patients with serrated polyposis syndrome: a multicenter, randomized, back-to-back trial. Gastrointest Endosc. 2015 Mar;81(3):531-8. doi: 10.1016/j.gie.2014.06.043. Epub 2014 Aug 1.

  PMID: 25088921 RESULT

• Boparai KS, van den Broek FJ, van Eeden S, Fockens P, Dekker E. Increased polyp detection using narrow band imaging compared with high resolution endoscopy in patients with hyperplastic polyposis syndrome. Endoscopy. 2011 Aug;43(8):676-82. doi: 10.1055/s-0030-1256447. Epub 2011 Aug 2.

  PMID: 21811939 RESULT

• Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.

  PMID: 24639382 RESULT

• Lopez-Vicente J, Rodriguez-Alcalde D, Hernandez L, Riu Pons F, Vega P, Herrero Rivas JM, Santiago Garcia J, Salces Franco I, Bustamante Balen M, Lopez-Ceron M, Pellise M; Endoscopy for High Risk Cancer Conditions group of the Spanish Gastroenterological Association and Spanish Digestive Endoscopy Society. Panchromoendoscopy Increases Detection of Polyps in Patients With Serrated Polyposis Syndrome. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2016-2023.e6. doi: 10.1016/j.cgh.2018.10.029. Epub 2018 Oct 24.

  PMID: 30366156 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jorge Lopez Vicente

  Hospital Universitario de Móstoles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are randomized into two groups with tandem explorations: in the group A or white light group (HR-WLE) where inspection is performed with white light in both colonoscopies, and in the group B or chromoendoscopy group (HR-CE) where a first inspection is performed with white light and the second with panchromoendoscopy with indigo carmine.

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 26, 2018
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share