Clinical trial NCT05253222: Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET
Official title: Methodology and Clinical Value of Retrograde Imaging Technique in Intestinal Obstructive Diseases Mediated by Colonic Transendoscopic Enteral Tubing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Microbiota Transplantation
Bowel Obstruction
Keywords: Washed Microbiota Transplantation
Fecal Microbiota Transplantation
Transendoscopic enteral tubing
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
name: Wuxi No. 2 People's Hospital
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
First posted: 2022-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE（Multi-slices spiral computed tomography enterography） and MRE（ Magnetic resonance enterography）require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD（Crohn's Disease） patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.


Eligibility criteria: Inclusion Criteria:

* Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation；
* Abdominal X-ray or plain CT showed signs of intestinal obstruction;
* Participants suspected with intestinal stricture according to the recent lower GI endoscopy；
* Voluntarily sign written informed consent.

Exclusion Criteria:

* Signs of peritonitis, perforation or massive hemorrhage of digestive tract;
* Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy;
* Allergic to laxatives or iodine contrast agents;
* Pregnant women;
* Confirmed or suspected claustrophobia;
* Inability to understand or provide informed consent

Primary outcomes:
measure: The diagnostic self-confidence score
timeFrame: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.
measure: Evaluation of comprehensive diagnostic efficiency
timeFrame: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.
Secondary outcomes:
measure: Adverse reaction
timeFrame: during the process, and no more than 24hours after CT/X-ray fluoroscopy detection
measure: Tolerance
timeFrame: during the process, and no more than 24hours after CT/X-ray fluoroscopy detection
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Faming Zhang, MD, PhD
role: STUDY_CHAIR
References:
citation: Rami Reddy SR, Cappell MS. A Systematic Review of the Clinical Presentation, Diagnosis, and Treatment of Small Bowel Obstruction. Curr Gastroenterol Rep. 2017 Jun;19(6):28. doi: 10.1007/s11894-017-0566-9.
citation: Catena F, De Simone B, Coccolini F, Di Saverio S, Sartelli M, Ansaloni L. Bowel obstruction: a narrative review for all physicians. World J Emerg Surg. 2019 Apr 29;14:20. doi: 10.1186/s13017-019-0240-7. eCollection 2019.
citation: Sheedy SP, Kolbe AB, Fletcher JG, Fidler JL. Computed Tomography Enterography. Radiol Clin North Am. 2018 Sep;56(5):649-670. doi: 10.1016/j.rcl.2018.04.002. Epub 2018 Jul 11.
citation: Masselli G, Gualdi G. CT and MR enterography in evaluating small bowel diseases: when to use which modality? Abdom Imaging. 2013 Apr;38(2):249-59. doi: 10.1007/s00261-012-9961-8.
citation: Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
citation: 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.