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

NCT05253222 | Unknown DMC

• 1 other identifier: TET2022N001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Microbiota Transplantation; Bowel Obstruction

Keywords

Washed Microbiota Transplantation; Fecal Microbiota Transplantation; Transendoscopic enteral tubing

Outcome Measures

Primary Outcomes (2)

• The diagnostic self-confidence score

  Image parameters of the lesion( i e. Location，Nature, Severity, Appearance, Fistula) will be recorded by the reader. The diagnostic self-confidence for each image parameter will be determined using a continuous five-grade scoring system from 1 to 5(1 = worst, 2=worsen, 3=normal, 4= better,5 = best). For example: The doctor's diagnostic self-confidence for Location is worsen ,then the diagnostic self-confidence score will be recorded as 2。

  immediately after CT/X-ray fluoroscopy detection，no more than 24hours.

• Evaluation of comprehensive diagnostic efficiency

  comprehensive diagnostic efficiency=(Location+Nature+Appearance+Fistula+Proximal lesion filled by contrast fluid）. Each positive parameter will be recorded as mark 1, negative mark 0. Each participant will get up to 5 score. For example: for some one participant ,if the doctor could determine the location and nature of the lesion, however,appearance, fistula and proximal lesion filled by contrast fluid could not be determined, then ,the score of comprehensive diagnostic efficiency equals 2.

  immediately after CT/X-ray fluoroscopy detection，no more than 24hours.

Secondary Outcomes (2)

• Adverse reaction

  during the process, and no more than 24hours after CT/X-ray fluoroscopy detection

• Tolerance

  during the process, and no more than 24hours after CT/X-ray fluoroscopy detection

Study Arms (1)

retrograde imaging by colonic TET

EXPERIMENTAL

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.

Diagnostic Test: retrograde image by colonic TET

Interventions

retrograde image by colonic TET DIAGNOSTIC_TEST

Delivery of contrast fluid by colonic TET Each participant will receive one delivery of 200 ml contrast fluid by colonic TET to the distal portion of the lesion. One group will be taken CT investigation, another group will be taken X-ray fluoroscopy. Imaging parameters will be collected and evaluated.

retrograde imaging by colonic TET

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (6)

• 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.

  PMID: 28439845 BACKGROUND

• 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.

  PMID: 31168315 BACKGROUND

• 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.

  PMID: 30119766 BACKGROUND

• 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.

  PMID: 23011551 BACKGROUND

• 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.

  PMID: 27556065 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Faming Zhang, MD, PhD

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

+8615005160383; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 23, 2022
• Study Start: March 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)