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Provided by Elsevier - Publisher Connector Egyptian Journal of Chest Diseases and (2016) 65, 711–716

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ORIGINAL ARTICLE Iatrogenic pneumodesis: Gelfoam flux inoculation in focal benign cavitary lung lesion

Ahmed M. Abumossalam a,*, Asem A. Hewidy a, Ahmed M. Abd El-khalek b

a Chest Department, Faculty of Medicine, Mansoura University, Egypt b Diagnostic Department, Faculty of Medicine, Mansoura University, Egypt

Received 27 January 2016; accepted 9 February 2016 Available online 5 April 2016

KEYWORDS Abstract Background: Pulmonary air-space containing cavities signify major dissuade that hold Gelfoam; gas exchange functions back and bring about recurrent suppuration. Lung cavity; Purpose: The aim of this work is to evaluate the impact of percutaneous local inoculation of Percutaneous; focal benign cavitary lung lesions with synthetic material (gelfoam) guided with chest computed CT chest tomography (CT) on the patient outcome based on clinical, laboratory, functional and radiological parameters. Patients and methods: A prospective simple randomized controlled trial was conducted on twenty eight patients with focal benign cavitary lung lesion less than 10 cm in diameter in whom surgical resection was contraindicated or refused. They were subdivided into two groups: group I (medically treated): 14 patients were followed up for three months with medical prophylaxis with quinolone plus clindamycin and group II (gelfoam inoculated): 14 patients percutaneous locally injected with gelfoam under CT guidance for a single session. Results: Gelfoam inoculated group (group II) presented more prevalence over medically treated group (group I) in the reduction of the frequency of infective exacerbations (71.42%), absence of leukocytosis (85.7%), functional improvement (42.85%), reduction of cavity size (57.14%) and cavitary obliteration (35.71%). Both groups were matched regarding the absence of and negative sputum cultures with high percentage (92.85%). However, reduction of the frequency of hospitalization predominated in group I. Significant statistical differences were present in radiological parameters only (reduction of size (0.042) and cavity obliteration (0.002). Success rate of procedure in the studied group was (35.71%). Conclusion: Percutaneous gelfoam injection may share in staged palliation and weeding out of pulmonary cavitary lesions with simple noninvasive image guided procedure. Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc- nd/4.0/).

* Corresponding author. Tel.: +20 1008424320. Introduction E-mail addresses: [email protected] (A.M. Abumossalam), [email protected] (A.M. Abd El-khalek). Peer review under responsibility of The Egyptian Society of Chest Cavities and cysts are commonly encountered lesions in the Diseases and Tuberculosis. lung on chest radiography and chest computed tomography http://dx.doi.org/10.1016/j.ejcdt.2016.02.004 0422-7638 Ó 2016 The Egyptian Society of Chest Diseases and Tuberculosis. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 712 A.M. Abumossalam et al.

CT. The differential diagnosis of such lesions is variable since Group I (medically treated group): 14 patients were many different processes of acquired or congenital origin can followed up for three months with medical prophylaxis in cause these abnormalities. Cysts and cavities are seen as foci the form of (levofloxacin 500 mg/day and clindamycin of decreased lung density with well defined walls [1,2].In 300 mg twice/day for five days per month) [13]. contrast, emphysematous airspaces usually lack such percepti- Group II (gel inoculated group): 14 patients were percuta- ble walls (bullae and blebs are exceptions) [3]. From the patho- neous locally injected under CT guidance with gelfoam flux logical point of view a cavity has been defined in as a gas-filled for a single session. space within a zone of pulmonary consolidation or within a The cases will be selected on a randomized basis according to mass or nodule, produced by the discharge of a necrotic part time of medical consultation one for group I and second for of the lesion via the bronchial tree and radiographically as a group II. Patients signed their written consents after detailed lucency within a zone of pulmonary consolidation, a mass, explanation of the study protocol. Local ethical approval had or a nodule; hence, a lucent area within the lung may or been obtained; clinical, laboratory, functional and radiological may not contain a fluid level and is surrounded by a wall, evaluation was conducted three months after the procedure. usually of variable thickness [4]. Cavities larger than 6 cm in Inclusion criteria: diameter or if symptoms last more than 12 weeks with appro- The term cavity is used to refer to an air-containing lesion priate , have little chances for only conservative heal- with a relatively thick (>4 mm) wall or within an area of a ing, and surgical therapy should be well thought-out, if surrounding infiltrate or mass while cyst wall ranged from 2 general condition allows [5]. Surgical resection of lung cavity to 4 mm in thickness [14]. is the treatment of choice for about 10% of patients. It is indi- Lung cavity less than 10 cm in diameter and >4 mm in wall cated in ineffectively treated more than 6 weeks, thickness or cyst <10 cm in diameter (2–4 mm wall) due to: suspicion on cancer and size more than 6 cm. Lobectomy is the resection of choice for large or central position of abscess. (1) Chronic lung cavity >3 months due to pyogenic or Atypical resection or segmentectomy are satisfactory fungal infections. procedures, if it is possible to remove complete abscess and (2) Chronic tuberculous lung cavities after verification of if necessary surrounding lung tissue with necrotizing pneumo- smear and culture negativity. nia [6]. Results of surgical treatment depend mostly on the (3) Simple non infected lung cyst. general condition and immunity of patient. Mortality rate after (4) Cavitary lung lesions due to (, surgical resections is about 11–28% [7]. Minimal invasive or Wagner’s granulomatosis). surgical procedures, such as video assisted thoracoscopy is a (5) Patient refused or contraindicated for . method of choice for peripheral localization of lung abscess without pleural adhesions and fibrothorax. Consequences of Exclusion criteria: this surgical procedure are satisfactory, but this intervention requires general anesthesia, double lumen endotracheal tube (1) Malignant lung cavity. [8]. Overall mortality in lung abscess treatment is about (2) Other pulmonary air-space containing cavities (emphy- 2.0–38.2% [9] with important roles of patient age, malnutri- sematous bullae, blebs, localized pneumothorax and tion, comorbidity, immunity, appropriate antibiotics and pneumatocele). supportive therapy. The usage of intra-cavitary fibrinolytic (3) Huge cavity more than 10 cm in diameter. agents (streptokinase, urokinase) is not recommended, because (4) Cavity with fluid level. the possibility of bronchopulmonary or bronchopleural fistula (5) Presence of active infection proved by fever, suppuration can occur [10]. and leucocytosis. Gelfoam sterile compressed sponge is a water-insoluble, hemostatic device prepared from purified porcine skin gelatin, The patients were evaluated with the following parameter and capable of absorbing up to 45 times its weight of whole before and after the end of the three months following the blood [11]. The absorptive capacity of gelfoam is a function procedure. of its physical size, increasing as the size of the gelatin sponge increases [12]. So our objective in this research was to evaluate Clinical parameter the impact of percutaneous local inoculation of focal benign cavitary lung lesions with synthetic material (gelfoam) guided (1) Reduction of the frequency of infective exacerbations with chest computed tomography on the patient outcome (purulent sputum >1 cup per day/fever/wheezes) less based on clinical, laboratory, functional and radiological than one per month. parameters. (2) Reduction of the frequency of hospital admission less than one visit in 3 month duration. Patients and methods (3) Absence of hemoptysis.

A prospective simple randomized controlled trial was conducted on twenty eight patients with focal benign cavitary Laboratory parameter lung lesion in whom surgical resection was contraindicated or refused. They were admitted in Chest Medicine Department (1) Absence of leukocytosis white blood cell count Mansoura University Hospitals during the period from <11.000/cubic mm. December 2014 to January 2016. They were subdivided into (2) Negative sputum culture (aerobic and anaerobic media two groups: and BACTEC). Iatrogenic pneumodesis 713

Functional parameter the form of pneumothorax, spillover or incorrect inoculation, gel leakage and hemoptysis. Serial was taken Spirogram (improvement of FEV1 more than 5.26%; based on in the consecutive two days for late complications as pneu- the fact that both lungs contain 19 segments so every segments monitis and spill over inoculation. Three months later all equals 1/19 of the lung hence, the degree of improvement could parameters were repeated for procedure evaluation in both be equalized to retaining functioning segment that = (1/19) groups as Fig. 1. * 100 = 5.26%) [15]. Statistical analysis Radiological parameter Data were analyzed using SPSS (Statistical Package for Social (1) By CT chest reduction in the size of the cavity. Sciences) version 21. Qualitative data were presented as num- (2) By CT chest obliteration of cavity. ber and percentage. Quantitative data were presented for nor- mality by Kolmogorov–Smirnov test. Normally distributed The procedure was considered successful if all parameters data were presented as mean and standard deviation. Compar- were fulfilled otherwise the procedure was categorized as failed ison between groups was done using Chi-square test. Student’s one. t-test was used to compare between two groups. P value <0.05 was considered significant. Procedure Results All patients in both groups received medical treatment for five days before starting the study and the clinical, laboratory, Table 1 offers knowledge about demographic data of the stud- functional and radiological; chest computed tomography (CT ied cases that were 21 male (21%) and 7 female (25%) with chest) were evaluated to ensure the absence of exacerbation median age 45 ± 13.05 in group I and 52 ± 14.23 in group and identify the preliminary parameters. II. Group I included 11 cases pyogenic abscess, 2 cases post- In group II, gelfoam flux was prepared by opening two tuberculous cavities and one lung cyst; on the other hand 10 ampoules (each ampoule contain gelfoam sponge with the fol- cases of pyogenic abscess and four cases due to tuberculosis lowing features (Curaspon; 80 * 50 * 10 mm EMOH Cura were enrolled in group II. Medical B.V.) and dividing them into small pieces under asep- Table 2 shows that gelfoam inoculated group (group II) tic technique then were enclosed into 50 cm syringe barrel from presented more prevalence over medically treated group its lower end then closing the plunger on the gelfoam then con- (group I) in the reduction of the frequency of infective exacer- nect this syringe with another one containing 25 cm saline bations (71.42%), absence of leukocytosis (85.7%), functional 0.9% by three way cannula then dissolving them by agitation improvement (42.85%), reduction of cavity size (57.14%) and method. Patients in group II were examined by computed cavitary obliteration (35.71%). Both groups were matched tomography scan for the localization of the site for entry that regarding the absence of hemoptysis and negative sputum cul- is identified on the surface of the skin by a mark then steriliza- tures with high percentage (92.85%). However, reduction of tion of the skin by betadine 5% followed by insertion of Chiba the frequency of hospitalization predominated in group I. Sig- needle with (15 cm length and 18 gauge to ensure injecting the nificant statistical differences were present in radiological jelly material) that connected to three ways connector one parameters only (reduction of size (0.042) and cavity oblitera- 50 cm syringe for application of negative pressure and another tion (0.002). Success rate of procedure in the studied group was 50 cm syringe that contain gelfoam flux as demonstrated in 35.71%. Fig. 2. After negative suction, the connector was opened with Table 3 showed that the incidence of complications encoun- gentle pressure for the inoculation of the flux. Immediate chest tered in our research was 21.42%; one case developed local CT chest cuts were taken to assess immediate complication in suppuration one case reported pneumothorax and one case

Figure 1 Computed tomography of chest illustrates CT chest of a 52 year old male with post-tuberculous cavitary lesion on the left hemi-thorax: (A) CT chest pre-procedure. (B) CT chest post-procedure showing reduction of cavitary size with partial obliteration 3 months after procedure (gelfoam inoculation) in transverse sections. 714 A.M. Abumossalam et al.

Figure 2 Demonstration of instruments used in inoculation procedure of gelfoam into cavitary lung lesion; Chiba needle, two syringe 50 cm two sponge of gelfoam.

Table 1 Demographic data in studied medically treated group and gelfoam inoculated one and types of cavitary lesions included. Group I medically treated Group II gelfoam inoculated Total group 14 cases group 14 cases Number and percent Number and percent Male 10 (71.42%) 11 (78.57%) 21 (75%) Female 4 (28.57%) 3 (21.42%) 7 (25%) Age (mean ± SD) 45 ± 13.05 52 ± 14.23 Type of cavitary lesion included Chronic pyogenic lung abscess 11 (78.57%) 10 (71.42%) 21 (75%) Post-tuberculous cavity 2 (14.28%) 4 (28.57%) 6 (21.42%) Lung cyst 1 (7.14%) 0 1 (3.57%)

Table 2 Assessment of clinical, laboratory, functional and radiological parameters between medically treated group and gelfoam inoculated one. Group I medically treated group 14 cases Group II gel inoculated group 14 cases P Number and percent Number and percent value Reduction of frequency of infective 9 (64.28%) 10 (71.42%) 0.885 exacerbations Reduction of frequency of hospitalizations 12 (85.7%) 11 (78.57%) 0.920 Absence of hemoptysis 13 (92.85%) 13 (92.85%) 0.241 Absence of Leukocytosis <11.000/cubic mm 11 (78.57%) 12 (85.7%) 0.083 Negative sputum cultures 13 (92.85%) 13 (92.85%) 0.241 Improvement in FEV1 (5.26%) 4 (28.57%) 6 (42.85%) 0.074 CT radiological reduction of cavity size 3 (21.42%) 8 (57.14%) 0.042 CT radiological obliteration of cavity 0 5 (35.71%) 0.002 (Successful procedure) – 5 (35.71%) (Failed procedure) – 9 (64.28%)

developed fever, however there was no reported mortality in regular basis aiming to provide service for those with pul- our study. monary disability or with averse surgical longing. Yet to our search no studies were conducted on the value of inoculating Discussion fillers specially gelfoam in pulmonary air containing spaces as cavitary lesions. But its physical inertia supported usage Still interventional procedures with minimal invasive approach in neurosurgical procedure in obliterating arteriovenous make their way to more and more clinical appliance on a malformation and as microsphere in embolotherapy as well Iatrogenic pneumodesis 715

more than other fillers used in promoted us Table 3 Complications of the gelfoam inoculation in patients to proceed in inoculating gelfoam keeping in our consideration of group II. conducting other material under more future interventional Complications of gelfoam inoculation Number and percent approach. Third, possibility of spontaneous resolution of these Local suppuration 1 (7.14%) cavitary lesions made some limitations in considering the Hemoptysis 0 reduction of the cavity size as a good radiological parameter. Spill over of gel foam to other lobes 0 Lastly studying huge cavities was hardly enough to inoculate Pneumonitis 0 large amount of this material for the fear of unanticipated Fever 1 (7.14%) complications that may endanger the patient life. Pneumothorax 1 (7.14%) Death 0 Total 3 (21.42%) Conclusions

Pulmonary cavitary gelfoam inoculation still stands a few steps behind a promising success as a palliative minimal invasive as application in lung transplantation and closure of modality. Its modest achievement presumes a favorable pros- bronchopleural fistulae gave us confidence to attempt this perity with some modifications in material used and lesion approach in our research. selection. More research on this material and its correlates In our work, in gelfoam inoculated group; reduction of the needs to be carried out for better evaluation and secure frequency of infective exacerbations (71.42%), absence of application. leukocytosis (85.7%), functional improvement (42.85%), reduction of cavity size (57.14%) and cavitary obliteration (35.71%) were dominant parameters. That may be attributed Conflict of interests to the inert non inflammatory effect of gelfoam sponge and absorbing capacity with subsequent organization. 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