Bowel Preparation for Magnetic Resonance Enterography

• ClinicalTrials.gov Identifier: NCT03541733
• Recruitment Status: Unknown
• First Posted: May 30, 2018
• Last Update Posted: November 30, 2018
• Sponsor: The Second Hospital of Nanjing Medical University
• Information provided by (Responsible Party): Faming Zhang, The Second Hospital of Nanjing Medical University

Study Description

Brief Summary:

Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).

Condition or disease	Intervention/treatment	Phase
Crohn Disease	Other: mid-gut tubing	Not Applicable

Detailed Description:

This is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) Tube group, mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube; (2) Oral group, administer contrast solution orally, mid-gut tubing after the MRE examination. The primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Bowel Preparation for Magnetic Resonance Enterography: a Open Label, Multicenter Randomized Controlled Trial
• Actual Study Start Date: June 1, 2018
• Estimated Primary Completion Date: June 1, 2019
• Estimated Study Completion Date: June 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tubing-group; mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube	Other: mid-gut tubing; mid-gut tubing at different time
No Intervention: Oral-group; administer contrast solution orally, mid-gut tubing after the MRE examination

Outcome Measures

Primary Outcome Measures :

1. grade of bowel distention [ Time Frame: one year ]
   grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention)
2. degree of discomfort [ Time Frame: one year ]
   using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe)

Secondary Outcome Measures :

1. accuracy of lesion detection [ Time Frame: one year ]
   accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring)

Eligibility Criteria

• Ages Eligible for Study: 14 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition);
• Age ≥ 14 years old.

Exclusion Criteria:

• Unable to understand or provide informed consent;
• Had difficulty in swallowing, or dysphagia;
• Allergic to laxative and/or contrast;
• Claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of MRI;
• Known or suspected intestinal obstruction or severe stricture.

Contacts and Locations

Contacts

Contact: Faming Zhang, MD; PHD; 086-025-58509883; fzhang@njmu.edu.cn

Locations

China, Jiangsu

Fmt-Dt-N-27/1350; Recruiting

Nanjing, Jiangsu, China, 210011

Contact: Faming Zhang, PhD,MD

Principal Investigator: Faming Zhang, MD,PhD

Sponsors and Collaborators

The Second Hospital of Nanjing Medical University

Investigators

• Principal Investigator: Faming Zhang, MD, PhD; The Second Hospital of Nanjing Medical University

More Information

Publications:

Ajaj W, Goehde SC, Schneemann H, Ruehm SG, Debatin JF, Lauenstein TC. Oral contrast agents for small bowel MRI: comparison of different additives to optimize bowel distension. Eur Radiol. 2004 Mar;14(3):458-64. Epub 2003 Nov 22.

Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.

Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. Epub 2007 Sep 25.

Negaard A, Paulsen V, Sandvik L, Berstad AE, Borthne A, Try K, Lygren I, Storaas T, Klow NE. A prospective randomized comparison between two MRI studies of the small bowel in Crohn's disease, the oral contrast method and MR enteroclysis. Eur Radiol. 2007 Sep;17(9):2294-301. Epub 2007 May 5.

Long C, Yu Y, Cui B, Jagessar SAR, Zhang J, Ji G, Huang G, Zhang F. A novel quick transendoscopic enteral tubing in mid-gut: technique and training with video. BMC Gastroenterol. 2018 Mar 13;18(1):37. doi: 10.1186/s12876-018-0766-2.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x.

• Responsible Party: Faming Zhang, Associate chief physician, associate professor, The Second Hospital of Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03541733
• Other Study ID Numbers: MRE-CN-180421
• First Posted: May 30, 2018
• Last Update Posted: November 30, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

magnetic resonance enterography; bowel preparation

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases