Change in Management Following Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates

NCT04998903 | Completed DMC

• 1 other identifier: 2141128
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Hematopoietic stem cell transplant (HSCT) is a modality that is increasingly utilized to treat various haematological disorders with a varying degree of success. From 2006 to 2019 use of HSCT worldwide has increased from 50,417 to an estimated 1.5 million. Disease relapse, graft versus host disease (GVHD) and infections are the leading causes of morbidity and mortality in patients with HSCT. Pulmonary complications, in particular, are common in patients with HSCT, and the diagnostic approach and management of these complications remain a challenge. FOB is one of the standard and least invasive diagnostic modality for these patients. However, the diagnostic yield and change in clinical decision making in those studies have been variable. Furthermore, all these studies were retrospective, with one exception. The investigators designed an observational study to understand the rate of change in clinical decision making following Fiberoptic bronchoscopy (FOB). The investigators also looked at the yield of FOB and characteristics associated with a positive diagnostic yield.

Conditions

Stem Cell Transplant Complications; Pulmonary Complication

Keywords

Stem cell transplant; Hematopoietic Stem Cell; Pulmonary infiltrates; Fiberoptic bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of change in clinical decision making following FOB

  number of patients whose clinical management changed directly as a consequence of fiberoptic bronchoscopy

  within 1 months of FOB

Secondary Outcomes (3)

• Clinical characteristics associated with a positive yield in Fiberoptic Bronchoscopy

  Within 2 weeks of presentation to FOB

• CT scan patterns associated with a positive yield in Fiberoptic Bronchoscopy

  CT within one month before the FOB

• Six month outcome of patients following FOB

  six months

Study Arms (1)

Stem cell transplant with Graft versus host disease

Patients who following hematopoietic stem cell transplant suffered from graft versus host disease and presented with pulmonary infiltrates.

Procedure: Fiberoptic Bronchoscopy

Interventions

Fiberoptic Bronchoscopy PROCEDURE

Fiberoptic bronchoscopy done under conscious sedation

Also known as: Broncho-alveolar lavage, Transbronchial biopsy

Stem cell transplant with Graft versus host disease

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was those who had HSCT and suffered from GVHD presenting with pulmonary infiltrates.

You may qualify if:

• All patients who suffered from GVHD following Hematopoietic Stem Cell Transplant and had Pulmonary Infiltrate's requiring Fiberoptic Bronchoscopy.

You may not qualify if:

• Any patients aged less than 14 years.
• Unable to consent
• Those patients who the primary physician decided not have Fiberoptic Bronchoscopy.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Centre

Riyadh, Saudi Arabia

Location

Related Publications (5)

• Gratwohl A, Pasquini MC, Aljurf M, Atsuta Y, Baldomero H, Foeken L, Gratwohl M, Bouzas LF, Confer D, Frauendorfer K, Gluckman E, Greinix H, Horowitz M, Iida M, Lipton J, Madrigal A, Mohty M, Noel L, Novitzky N, Nunez J, Oudshoorn M, Passweg J, van Rood J, Szer J, Blume K, Appelbaum FR, Kodera Y, Niederwieser D; Worldwide Network for Blood and Marrow Transplantation (WBMT). One million haemopoietic stem-cell transplants: a retrospective observational study. Lancet Haematol. 2015 Mar;2(3):e91-100. doi: 10.1016/S2352-3026(15)00028-9. Epub 2015 Feb 27.

  PMID: 26687803 RESULT

• Styczynski J, Tridello G, Koster L, Iacobelli S, van Biezen A, van der Werf S, Mikulska M, Gil L, Cordonnier C, Ljungman P, Averbuch D, Cesaro S, de la Camara R, Baldomero H, Bader P, Basak G, Bonini C, Duarte R, Dufour C, Kuball J, Lankester A, Montoto S, Nagler A, Snowden JA, Kroger N, Mohty M, Gratwohl A; Infectious Diseases Working Party EBMT. Death after hematopoietic stem cell transplantation: changes over calendar year time, infections and associated factors. Bone Marrow Transplant. 2020 Jan;55(1):126-136. doi: 10.1038/s41409-019-0624-z. Epub 2019 Aug 27.

  PMID: 31455899 RESULT

• Harris B, Geyer AI. Diagnostic Evaluation of Pulmonary Abnormalities in Patients with Hematologic Malignancies and Hematopoietic Cell Transplantation. Clin Chest Med. 2017 Jun;38(2):317-331. doi: 10.1016/j.ccm.2016.12.008.

  PMID: 28477642 RESULT

• Lim DH, Lee J, Lee HG, Park BB, Peck KR, Oh WS, Ji SH, Lee SH, Park JO, Kim K, Kim WS, Jung CW, Park YS, Im YH, Kang WK, Park K. Pulmonary complications after hematopoietic stem cell transplantation. J Korean Med Sci. 2006 Jun;21(3):406-11. doi: 10.3346/jkms.2006.21.3.406.

  PMID: 16778380 RESULT

• Lucena CM, Torres A, Rovira M, Marcos MA, de la Bellacasa JP, Sanchez M, Domingo R, Gabarrus A, Mensa J, Agusti C. Pulmonary complications in hematopoietic SCT: a prospective study. Bone Marrow Transplant. 2014 Oct;49(10):1293-9. doi: 10.1038/bmt.2014.151. Epub 2014 Jul 21.

  PMID: 25046219 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchoalveolar lavage (BAL) BAL - cytology

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pulmonologist

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 10, 2021
• Study Start: May 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: February 27, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)