Endoscopic Surveillance in Serrated Polyposis Syndrome and Low-risk of Advanced Neoplasia

NCT04906343 | Completed

• 1 other identifier: HUMostoles2021005
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine if Serrated Poliposis Syndrome (SPS) patients with SPS criteria, with clearing phase achieved and without any advanced lesion or less than 5 relevant lesions at last colonoscopy have the same advanced neoplasia incidence in the surveillance colonoscopy at 2 or 3 years. Patients selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years. Randomization will be done at the database program (RedCAP). All colonoscopies will be performed with high definition (HD) system and it will be the choice of the endoscopist whether to use chromoendoscopy with indigo carmine o virtual chromoendoscopy. Protocol bowel preparation will be recommended by each centre. Sedation will be prescribed and decided by the endoscopist during the examination. Data from all the resected and visualized lesions during the colonoscopy will be collected on the database. A pathologist familiarized with serrated lesions will be in charge of the sample analysis. Serrated lesions will be classified attending de WHO criteria for serrated lesions. The investigators define "advanced adenoma" as adenomas ≥10 mm with villous histology and/or with high grade of dysplasia (HGD). The investigators define "advanced SL" as any SL ≥10mm and any SL with dysplasia. The investigators also define "advanced neoplasia" as any colorectal cancer (CRC), any advanced adenoma or advanced Serrated Lesions (SL). Quality of bowel cleansing will be graded by each endoscopist following the Boston Bowel Preparation Scale. This scale evaluates each segment (ascending colon, transverse colon and descending colon) of the following form: 0 = segment of colon whose mucosa cannot be seen due to the existence of solid stools that cannot be eliminated; 1 = mucosa portion of a colonic segment that can be seen, but other areas of the colonic segment are not seen, either due to the presence of dirt, feces or opaque liquid; 2 = existence of small amount of dirt, small fragments of stool and / or opaque liquid, but the mucosa of the colonic segment can be seen well; 3 = all the mucosa of the colonic segment can be seen well without residual dirt, small traces of stool or opaque liquid. Patients with inadequate preparation (when in any segment the score is 0 or 1, or the total score is less than 6) will be excluded from the study. During colonoscopy all complications as post-polypectomy bleeding, perforation or cardio-respiratory events will be registered. Those complications will be considered if surgery or hospital admission is required.

Conditions

Colonic Polyp; Colonic Neoplasms; Colonic Cancer; Serrated Polyposis; Serrated Polyp of Colon

Keywords

Serrated Polyposis Syndrome; endoscopic surveillance; sesil serrated lesion

Outcome Measures

Primary Outcomes (2)

• Advanced neoplasia and colorectal cancer incidence at 2 years

  Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 2 year colonoscopy.

  2 years

• Advanced neoplasia and colorectal cancer incidence at 3 years

  Number of CCR and advanced neoplasia detected in SPS patients with low risk factors of advanced neoplasia during surveillance after a 3 year colonoscopy.

  3 years

Study Arms (2)

Group 1 (2 years)

NO INTERVENTION

Group 1, surveillance colonoscopy in two years after the last complete colonoscopy in SPS patient.

Group 2 (3 years)

ACTIVE COMPARATOR

Group 2, surveillance colonoscopy in three years after the last complete colonoscopy in SPS patient.

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Colonoscopy surveillance in SPS patient after 3 years of the last colonoscopy.

Group 2 (3 years)

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 aged 18 years or older that fulfil WHO criteria 1 or 2 of SPS:
• Criteria 1: any patient with ≥ 5 SL proximal to the rectum, all ≥5 mm in size, with at least 2 ≥10 mm in size.
• Criteria 2: any patient with \>20 SL of any size distributed throughout the colon, with ≥5 lesions proximal to the rectum.
• Patients with a previous complete colonoscopy with adequate bowel preparation and with all lesions \>5mm been resected ("clearance colonoscopy), after the diagnostic of SPS.
• Nor advanced adenoma or serrated lesions at prior colonoscopy, and also either more than 5 relevant lesion (adenoma, SSL or PH\>5mm) at prior colonoscopy.

You may not qualify if:

• Patients with no inform consent or who do not agree to participate in the study.
• Patients with total or partial colectomy.
• Patients with other CCR predisposing syndromes with germinal mutation (Familial adenomatous polyposis, Lynch syndrome, Peutz-Jehgers syndrome, Cowden syndrome, Juvenile polyposis syndrome…).
• Patients with chronic inflammatory bowel disease.
• Patients with coagulation disorders.
• Fragmented lesion or submucosal invasive lesion at last colonoscopy.
• Inadequate colon preparation: any segment of the colon with \<2 points in Boston Scale (BBPS).

Sponsors & Collaborators

• Hospital Universitario de Móstoles: lead

Study Sites (1)

Jorge López Vicente

Móstoles, Madrid, 282935, Spain

Location

Related Publications (8)

• European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.

  PMID: 23212726 BACKGROUND

• Monahan KJ, Bradshaw N, Dolwani S, Desouza B, Dunlop MG, East JE, Ilyas M, Kaur A, Lalloo F, Latchford A, Rutter MD, Tomlinson I, Thomas HJW, Hill J; Hereditary CRC guidelines eDelphi consensus group. Guidelines for the management of hereditary colorectal cancer from the British Society of Gastroenterology (BSG)/Association of Coloproctology of Great Britain and Ireland (ACPGBI)/United Kingdom Cancer Genetics Group (UKCGG). Gut. 2020 Mar;69(3):411-444. doi: 10.1136/gutjnl-2019-319915. Epub 2019 Nov 28.

  PMID: 31780574 BACKGROUND

• East JE, Atkin WS, Bateman AC, Clark SK, Dolwani S, Ket SN, Leedham SJ, Phull PS, Rutter MD, Shepherd NA, Tomlinson I, Rees CJ. British Society of Gastroenterology position statement on serrated polyps in the colon and rectum. Gut. 2017 Jul;66(7):1181-1196. doi: 10.1136/gutjnl-2017-314005. Epub 2017 Apr 27.

  PMID: 28450390 BACKGROUND

• Bleijenberg AG, IJspeert JE, van Herwaarden YJ, Carballal S, Pellise M, Jung G, Bisseling TM, Nagtegaal ID, van Leerdam ME, van Lelyveld N, Bessa X, Rodriguez-Moranta F, Bastiaansen B, de Klaver W, Rivero L, Spaander MC, Koornstra JJ, Bujanda L, Balaguer F, Dekker E. Personalised surveillance for serrated polyposis syndrome: results from a prospective 5-year international cohort study. Gut. 2020 Jan;69(1):112-121. doi: 10.1136/gutjnl-2018-318134. Epub 2019 Apr 13.

  PMID: 30981990 BACKGROUND

• Rodriguez-Alcalde D, Castillo-Lopez G, Lopez-Vicente J, Hernandez L, Lumbreras-Cabrera M, Moreno-Sanchez D. Long-Term Incidence of Advanced Colorectal Neoplasia in Patients with Serrated Polyposis Syndrome: Experience in a Single Academic Centre. Cancers (Basel). 2021 Mar 3;13(5):1066. doi: 10.3390/cancers13051066.

  PMID: 33802297 BACKGROUND

• Bleijenberg AGC, IJspeert JEG, Rodriguez-Alcalde D, Carballal S, Visser MR, Pellise M, Koornstra JJ, Rana SA, Latchford A, Balaguer F, Dekker E. The (ir)relevance of the abandoned criterion II for the diagnosis of serrated polyposis syndrome: a retrospective cohort study. Fam Cancer. 2020 Apr;19(2):153-160. doi: 10.1007/s10689-019-00156-2.

  PMID: 31853684 BACKGROUND

• Bleijenberg AGC, IJspeert JEG, Carballal S, Pellise M, Jung G, van Herwaarden YJ, Bisseling TM, Nagtegaal ID, van Leerdam ME, Spaander MCW, van Lelyveld N, Bessa X, Rodriguez-Alcalde D, Bastiaansen BAJ, de Klaver W, Bemelman WA, Bujanda L, Koornstra JJ, Rivero L, Rodriguez-Moranta F, Balaguer F, Dekker E. Low Incidence of Advanced Neoplasia in Serrated Polyposis Syndrome After (Sub)total Colectomy: Results of a 5-Year International Prospective Cohort Study. Am J Gastroenterol. 2019 Sep;114(9):1512-1519. doi: 10.14309/ajg.0000000000000339.

  PMID: 31403493 BACKGROUND

• Rodriguez-Alcalde D, Carballal S, Moreira L, Hernandez L, Rodriguez-Alonso 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, Saperas E, Lopez-Ceron M, Cuatrecasas M, Lopez-Vicente J, Rivero-Sanchez L, Jung G, Vila-Casadesus M, Sanchez A, Castells A, Pellise M, Balaguer F; Gastrointestinal Oncology Group of the Spanish Gastroenterological Association. High incidence of advanced colorectal neoplasia during endoscopic surveillance in serrated polyposis syndrome. Endoscopy. 2019 Feb;51(2):142-151. doi: 10.1055/a-0656-5557. Epub 2018 Aug 1.

  PMID: 30068004 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Interventions

Colonoscopy

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

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 selected for the study will be randomised in two groups for the surveillance: group 1, surveillance with colonoscopy in two years; group 2, surveillance with colonoscopy in three years.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 28, 2021
• Study Start: June 5, 2021
• Primary Completion: October 2, 2024
• Study Completion: November 22, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)