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

Colonic Neoplasms Clinical Trial

— ADACOLON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557216
• Other study ID #: ADACOLON
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: August 23, 2022

Study information

• Verified date: April 2022
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: August 23, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Diverticulitis
• Diverticulitis, Colonic

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Parc de Salut Mar. Hospital del Mar.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Daniels L, Unlü 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. Review. — View Citation

Laméris 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CT predictive value for ACN detection	Assessment of diagnostic prediction of computed tomography to detect ANC in acute diverticulitis.	At the moment of colonoscopy.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	FIT predictive value for ANC detection	Assessment of diagnostic prediction of FIT to detect ANC in acute diverticulitis.	At the moment of colonoscopy.
Secondary	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.