Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET (RIT;TET)

Nanjing Medical University

Status: Unknown

Conditions: Bowel Obstruction; Fecal Microbiota Transplantation

Treatments: Diagnostic Test: retrograde image by colonic TET

Study type: Interventional

Funder types: Other

Identifiers

NCT05253222

TET2022N001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

retrograde imaging by colonic TET

Experimental group

Description:

Contrast fluid will be injected through colonic TET in participants with bowel obstruction. Image parameters detected by CT and X-ray fluoroscopy will be evaluated.

Treatment:

Diagnostic Test: retrograde image by colonic TET