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

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?

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).

Study Overview

• Status: Unknown
• Conditions: Bowel Preparation
• Intervention / Treatment: Device: Capsule endoscopy; Drug: Polyethylene Glycol

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pedro Magalhães-Costa, MD; Phone Number: 00351-96-3532531; Email: pmagalhaescosta@gmail.com

Study Locations

• Portugal
  • Lisboa, Portugal, 1349-019 Lisboa
    • Recruiting
    • Gastroenterology Department, Hospital Egas Moniz
    • Contact: Pedro Magalhães-Costa, MD; Phone Number: 00351963532531; Email: pmagalhaescosta@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-dose Polyethylene Glycol regimen; Drug: Polyethylene Glycol Intervention: 2 liters of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion.	Device: Capsule endoscopy; Endoscopic device; Drug: Polyethylene Glycol; Bowel purgative; Other Names: PEG
Experimental: Split-dose Polyethylene Glycol regimen; Drug: Polyethylene Glycol Intervention: 1 liter of Polyethylene Glycol will be given in the day before Capsule Endoscopy ingestion and another 1 liter Polyethylene Glycol will be given in the same day of Capsule Endoscopy ingestion.	Device: Capsule endoscopy; Endoscopic device; Drug: Polyethylene Glycol; Bowel purgative; Other Names: PEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The transit time	Compare gastric transit time and the small bowel transit time.	at the end of capsule endoscopy exploration

Collaborators and Investigators

• Sponsor: Centro Hospitalar Lisboa Ocidental
• Investigators: Study Director: Cristina Chagas, MD, Gastroenterology Department, Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Magalhaes-Costa P, Carmo J, Bispo M, Santos S, Chagas C. Superiority of the Split-dose PEG Regimen for Small-Bowel Capsule Endoscopy: A Randomized Controlled Trial. J Clin Gastroenterol. 2016 Aug;50(7):e65-70. doi: 10.1097/MCG.0000000000000460.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SPLIT-PEG-CE