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Surveillance of Allograft Rejection After Intestinal Transplantation Using Endoscopy

NCT03616548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-06

No results posted yet for this study

Summary

Intestinal failure (IF) which are characterized by inadequate maintenance of nutrition via normal intestinal function comprises a group of disorders with many different causes. If IF persists for more than a few days, it demands treatment with the intravenous supplement of water and nutrients, so-called parenteral nutrition (PN), to avoid life-threatening complications. However, PN dependency is associated with higher mortality and is therefore considered to have indications for intestine transplantation (IT). Graft acute cellular rejection is one of the most important reasons for graft failure. As a result, early identification of ACR and timely modification of anti-rejection medications has been considered to be associated with better graft and patient survivals. The diagnostic gold standard for ACR is mainly based on histology, but hours of delay by pathology may occur. Additionally, immunity in small bowel after transplantation should rely on a balance of innate and adaptive immune responses in the presence of the gut microbiota which the distribution may change after IT. Few researches investigated the association of changes of gut microbiota with graft rejection and narrow-band imaging endoscopy which can provide timely diagnosis of ACR in IT patients. In this study, we aimed to investigate the association of changes in mucosa-associated microbiota which was not addressed in the literature with rejection reaction by next-generation sequencing methods. We also use a new endoscopic scoring system to evaluate the diagnostic accuracy of rejection reaction using pathology as standard reference.

Conditions

  • Rejection of an Intestine Transplant

Interventions

DIAGNOSTIC_TEST

Endoscopic surveillance

Magnifying endoscopy under narrow band imaging system via chimney ileostomy after intestinal transplantation

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Chen Shuan Chung, MD, MSc · Department of Internal Medicine, Far Eastern Memorial Hospital

Study Design

Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2020-07-01
Completion
2020-07-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616548 on ClinicalTrials.gov