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

NCT ID: NCT05253222

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

retrograde imaging by colonic TET

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.

Group Type: EXPERIMENTAL

retrograde image by colonic TET

Intervention Type: 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.

Interventions

retrograde image by colonic TET

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Wuxi No. 2 People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Associate professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD, PhD

Role: STUDY_CHAIR

Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Faming Zhang, MD,PhD

Role: CONTACT

fzhang@njmu.edu.cn

+8615005160383

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

+86-025-58509883

References

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.

Reference Type: BACKGROUND

PMID: 28439845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31168315 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30119766 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23011551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27556065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30606236 (View on PubMed)

Other Identifiers

TET2022N001

Identifier Type: -

Identifier Source: org_study_id