Bowel Preparation for Magnetic Resonance Enterography

NCT03541733 | Completed DMC

• 1 other identifier: MRE-CN-180421
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease

Keywords

magnetic resonance enterography; bowel preparation

Outcome Measures

Primary Outcomes (2)

• grade of bowel distention

  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)

  one year

• degree of discomfort

  using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe)

  one year

Secondary Outcomes (1)

• accuracy of lesion detection

  one year

Study Arms (2)

Tubing-group

EXPERIMENTAL

mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube

Other: mid-gut tubing

Oral-group

NO INTERVENTION

administer contrast solution orally, mid-gut tubing after the MRE examination

Interventions

mid-gut tubing OTHER

mid-gut tubing at different time

Tubing-group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Wuxi No. 2 People's Hospital: collaborator

Study Sites (1)

Fmt-Dt-N-27/1350

Nanjing, Jiangsu, 210011, China

Location

Related Publications (7)

• 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. doi: 10.1007/s00330-003-2177-0. Epub 2003 Nov 22.

  PMID: 14634782 BACKGROUND

• 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.

  PMID: 25168749 BACKGROUND

• 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. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25.

  PMID: 17899102 BACKGROUND

• 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. doi: 10.1007/s00330-007-0648-4. Epub 2007 May 5.

  PMID: 17483955 BACKGROUND

• 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.

  PMID: 29534703 BACKGROUND

• Wang Y, Dai M, Zheng M, Jin Y, Wen Q, Cui B, Zhang Z, Zhu J, Zhang F. Bowel preparation after mid-gut tubing enhanced the efficacy and compliance of magnetic resonance enterography in Crohn's disease: a randomized controlled trial. Therap Adv Gastroenterol. 2024 Sep 26;17:17562848241275337. doi: 10.1177/17562848241275337. eCollection 2024.

  PMID: 39346010 DERIVED

• 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.

  PMID: 30606236 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Faming Zhang, MD, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician, associate professor

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: May 30, 2018
• Study Start: June 1, 2018
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)