Clinical trial NCT00613860: Sequential Endoscopic Lung Volume Reduction
Official title: Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Emphysema
COPD
Keywords: Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Humboldt-Universität zu Berlin
First posted: 2008-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.

Detailed description: Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.

Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30

Eligibility criteria: Inclusion Criteria:

* Heterogenous emphysema
* FEV1 \< 45%
* RV \> 150%
* TLC \> 100%
* TLCO \< 40%

Exclusion Criteria:

* Homogeneous emphysema
* Pregnancy
* PCO2 \> 50 mmHg

Primary outcomes:
measure: FEV 1 6 Minute walk test
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Safety Symptom scores
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, University of Berlin
city: Heidelberg
country: Germany
facility: Thoraxklinik, University of Heidelberg
city: Nürnberg
country: Germany
facility: Medical Center Nürnberg
Study officials:
affiliation: Thoraxklinik University of Heidelberg
name: Felix JF Herth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.
citation: de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
citation: Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7. doi: 10.1016/j.athoracsur.2004.07.048.
citation: Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73. doi: 10.1016/j.jtcvs.2003.10.005.
citation: Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.