Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy

Bowel Preparation Clinical Trial

Official title:

Split-dose Versus Single-dose Polyethylene Glycol Regimen for Capsule Endoscopy Is Timing of Preparation for Capsule Endoscopy the Key for the Best Small-bowel Cleansing?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02396017
• Other study ID #: SPLIT-PEG-CE
• Status: Recruiting
• Phase: Phase 4
• First received: February 18, 2015
• Last updated: March 23, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: Pedro Magalhães-Costa, MD
• Phone: 00351-96-3532531
• Email: pmagalhaescosta[@]gmail.com
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial Summary

To compare the small bowel cleanliness for wireless capsule endoscopy using two different Polyethylene Glycol administration schedules (before the wireless capsule endoscopy ingestion versus in a split-dose fashion).

Description:

The image quality obtained from the wireless capsule endoscopy improves its diagnostic yield. The amount of visualized mucosa is in direct correlation with the diagnostic yield. Nonetheless, frequently, the quality of the image obtained is hampered by the presence of bubbles, debris, bile and enteric fluid. Therefore many efforts have been putted in order to eliminate this factor such as the use of prokinetics, simethicone and bowel purgatives. The latter (namely the polyethylene glycol - PEG - solution) has accumulated evidence and is, therefore, recommended by the last European guidelines. Usually, the cleansing starts and finish in the day before the capsule endoscopy ingestion.

We hypothesized that, similarly to what had become evidence to large bowel cleansing, a shorter gap between the polyethylene glycol intake and the exam could provide a better capsule endoscopy image quality and therefore gauging our diagnostic yield.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients referred to our institution for CE during the study period

Exclusion Criteria:

• inpatients, bedridden, patients with clinical evidence of active bleeding, past history of abdominal surgery, abdominal or pelvic radiation therapy, occlusion, bowel perforation (suspected or confirmed), use of oral iron replacement therapy, severe cardiopulmonary, renal or hepatic disease, pregnancy, hypersensitivity to any components of the preparation, patients that didn't complete the preparation protocol, patients with incomplete enteroscopies (a complete enteroscopy is defined by the visualization of the mucosa from the duodenal bulb to the cecum), patients enrolled in other clinical studies and patients who didn't signed informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Device:
• Capsule endoscopy
Endoscopic device

Drug:
• Polyethylene Glycol
Bowel purgative

Locations

Country	Name	City	State
Portugal	Gastroenterology Department, Hospital Egas Moniz	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Brotz C, Nandi N, Conn M, Daskalakis C, DiMarino M, Infantolino A, Katz LC, Schroeder T, Kastenberg D. A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Gastrointest Endosc. 2009 Feb;69(2):262-70, 270.e1. doi: 10.1016/j.gie.2008.04.016. Epub 2008 Oct 11. — View Citation

Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18. — View Citation

Ladas SD, Triantafyllou K, Spada C, Riccioni ME, Rey JF, Niv Y, Delvaux M, de Franchis R, Costamagna G; ESGE Clinical Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010 Mar;42(3):220-7. doi: 10.1055/s-0029-1243968. Epub 2010 Mar 1. — View Citation

Rokkas T, Papaxoinis K, Triantafyllou K, Pistiolas D, Ladas SD. Does purgative preparation influence the diagnostic yield of small bowel video capsule endoscopy?: A meta-analysis. Am J Gastroenterol. 2009 Jan;104(1):219-27. doi: 10.1038/ajg.2008.63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small-bowel cleanliness	The cleansing quality of the small-bowel will be evaluated according to the system validated by Brotz et al., using the quantitative index (QI), because this score is less susceptible to the subjective element. The used cut-off value accepted for an adequate small-bowel cleansing was = 8 points.	at the end of capsule endoscopy exploration	No
Secondary	The number of all the observed lesions	Estimate the number of all the observed lesions on the recording according to their hemorrhagic potential.	at the end of capsule endoscopy exploration	No
Secondary	The clinical tolerance questionnaire	Evaluate the clinical tolerance and the acceptability of the bowel preparation with the oral polyethylene glycol solution.	at the end of capsule endoscopy exploration	Yes
Secondary	The transit time	Compare gastric transit time and the small bowel transit time.	at the end of capsule endoscopy exploration	No