Acute Diverticulitis and Advanced Colonic Neoplasia. When to Perform Colonoscopy (ADACOLON Study) (ADACOLON)

Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis

This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms; Diverticulitis, Colonic
• Intervention / Treatment: Diagnostic test: Colonoscopy; Diagnostic test: Fecal immunochemical and occult blood test; Diagnostic test: Fecal calprotectin test

Detailed Description

This is a prospective study that eliminates biases in the selection, design and variability of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia (ACN) and the difference in prevalence among populations with complicated and uncomplicated acute diverticulitis diagnosed by computed tomography. Another objective is to assess the diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the presence of clinical risk symptoms or the performance of fecal biological tests could help in narrowing the indication of colonoscopy in this clinical scenario.

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar. Hospital del Mar.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study inclusion period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion.

Exclusion Criteria:

1. Patient refusal to participate in the study.
2. Impossibility of obtaining informed consent by the patient or guardian.
3. Age <18 years and> 85 years
4. Impossibility of performing a diagnostic CT of AD.
5. Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complicated diverticulitis; Patients with complicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.	Diagnostic test: Colonoscopy; Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities; Diagnostic test: Fecal immunochemical and occult blood test; A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.; Other Names: FIT; Diagnostic test: Fecal calprotectin test; Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.
Experimental: Uncomplicated diverticulitis; Patients with uncomplicated diverticulitis diagnosed by computed tomography. Colonoscopy, Fecal immunochemical and occult blood test (FIT) and fecal calprotectin test wil be performed.	Diagnostic test: Colonoscopy; Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities; Diagnostic test: Fecal immunochemical and occult blood test; A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.; Other Names: FIT; Diagnostic test: Fecal calprotectin test; Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of ACN	For our study, ANC is all colonic lesions that are advanced adenoma or colorectal cancer. Advanced adenoma is defined as that adenoma with size> 10mm, villous component in> 25% and / or high-grade dysplasia or all serrated lesions> 10mm with or without dysplasia. Colonoscopy is the gold standard for ANC detection.	At the moment of colonoscopy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT predictive value for ACN detection	Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.	At the moment of colonoscopy.
Clinical symptoms predictive value for ANC detection	Assessment of diagnostic prediction of clinical symptoms to detect ANC in acute diverticulitis.	At the moment of colonoscopy.
Colonoscopy quality	A quality colonoscopy will be considered as a complete colonoscopy, with an adequate preparation according to the Boston scale (score greater than or equal to 2 in all segments) and with resection of all polyps <20mm detected.	At the moment of colonoscopy.
Colonoscopy security	Assessment of complications arising from colonoscopy. Mayor complication of colonoscopy is defined as the presence of perforation, hemorrhage, postpolypectomy syndrome, thromboembolic accident, acute myocardial infarction and / or death, and minor complication of colonoscopy for the rest of the events.	30 days post-colonoscopy.
FIT predictive value for ANC detection	Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.	At the moment of colonoscopy.
Fecal calprotectin test predictive value for ANC detection	Assessment of diagnostic prediction of fecal calprotectin test to detect ANC in acute diverticulitis.	At the moment of colonoscopy.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Agustín Seoane Urgorri, MD, Parc de Salut Mar. Hospital del Mar.

Publications and helpful links

General Publications

• Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available.
• Daniels L, Unlu C, de Wijkerslooth TR, Dekker E, Boermeester MA. Routine colonoscopy after left-sided acute uncomplicated diverticulitis: a systematic review. Gastrointest Endosc. 2014 Mar;79(3):378-89; quiz 498-498.e5. doi: 10.1016/j.gie.2013.11.013. Epub 2014 Jan 14. No abstract available.
• Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Diverticulitis; Advanced colonic neoplasm
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Diverticular Diseases; Diverticulosis, Colonic; Diverticulitis; Colonic Neoplasms; Diverticulitis, Colonic
• Other Study ID Numbers: ADACOLON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access will be shared with the principal investigators of all the hospitals that participate in the study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No