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Oxidized resorbable cellulose (Gelita-cel) causing foreign body reaction in the mediastinum

Oxidized resorbable cellulose (Gelita-cel) causing foreign body reaction in the mediastinum Abstract Different types of oxidized cellulose have been used for haemorrhage control in thoracic surgery, abdominal surgery and neurosurgery. Oxidized resorbable cellulose (Gelita-cel) is a new haemostatic agent. Once saturated with blood, it swells and makes a gelatinous mass that formats as a fibrin clot. We have performed a prospective observational cohort study of patients operated for lung cancer or suspected lung cancer using Gelita-cel as a haemostatic agent. Between October 2010 and April 2012, 477 patients were operated in our department for lung cancer. Gelita-cel was used in 200 patients due to minor intraoperative haemorrhage after lymph node resection from Stations 2 to 11. During follow-up for lung cancer, computed tomography, which was performed 4–60 months after the primary operation, showed enlarged lymph nodes in the mediastinum in 16 patients. Endoscopic bronchial ultrasonographic biopsies of the lymph nodes showed foreign body material and granulomatous inflammation, and no sign of lung cancer recurrence. Gelita-cel has a high risk of causing granuloma and should not be used as a haemostatic agent in thoracic surgery. Oxidized cellulose , Granuloma , Mediastinum , Haemostasis , Video-assisted thoracoscopic surgery INTRODUCTION Bleeding after pulmonary resection occurs approximately in 2% of patients after video-assisted thoracoscopic surgery (VATS) and in 1–3% of patients after thoracotomy [1–3]. Different types of oxidized cellulose have been used for haemorrhage control in thoracic surgery, abdominal surgery and neurosurgery. Absorbability and haemostatic effect of different oxidized cellulose has been compared in animals and humans [4–6] with different results. Oxidized resorbable cellulose (Gelita-cel, Gelita Medical, Germany) is a new haemostatic agent. ‘Once saturated with blood, it swells and makes a gelatinous mass that formats as a fibrin clot. It provides a strong matrix for platelet adhesion [7]. The product’s low pH causes localized vasoconstriction, further enhancing the haemostatic effect. In addition, the low pH exhibits antibacterial properties, minimizing the risk of infection’ [7]. It is extracted from natural alpha-grade cotton and is a 100% biodegradable organic material [7]. The oxidized cellulose degrades into oligosaccharides and creates an acidic environment that is a possible cause for anti-inflammatory and antiproliferative effect [4–6]. However, different studies and data show persisting deposits after inserting oxidized cellulose and were mistaken recurrent malignancies tumours and abscesses [9, 10]. PATIENTS AND METHODS We have performed a prospective observational cohort study of patients operated for lung cancer or suspected lung cancer in our department using a standardized anterior VATS approach [8]. Between October 2010 and April 2012, we operated on 477 patients. Gelita-cel was used in 200 patients due to minor intraoperative haemorrhage after lymph node dissection, mainly in the superior mediastinum (lymph node stations 2 and 4) or in the subcarinal area (lymph node station 7). Of these, we report on 16 patients who underwent VATS lobectomy n = 15 and wedge resection n = 1. The mean age of the patients was 60 years. Fourteen (87%) patients were smokers, 2 (13%) patients received anticoagulation therapy, which was stopped prior to surgery according to the guidelines. Positron emission tomography–computed tomography (PET-CT), CT and chest X-ray were performed prior to surgery in patients with suspected tumour. All patients were enrolled in a follow-up programme with CT of thorax and abdomen 4–60 months after the primary operation. Preoperatively, CT-guided samples from tumours were performed in 8 (50%) patients. Six patients were diagnosed with non-small-cell lung cancer and 2 had none of the representative materials. Six (37%) patients underwent preoperative endobronchial ultrasonography. The mean preoperative lung function was forced expiratory volume 2.09 and forced expiratory volume 68.9% ± standard deviation of the expected value (Table 1). The TNM Classification of Malignant Tumours was used as standard procedure to classify the tumours. VATS right upper lobectomy was performed in 8 (50%) patients and VATS middle lobe lobectomy in 1 (6%) patient. VATS left upper lobectomy was performed in 3 (19%) patients, 3 (19%) patients underwent VATS lower left lobectomy and 1 (6%) patient underwent VATS left upper wedge resection. Lymph node dissection with the removal of fatty tissue and lymph nodes was performed in Stations 2, 4 and 7–11 on the right side and in Stations 5–11 on the left side and were sent to the pathology department. PET scan was not taken postoperatively. Table 1: Clinicopathological characteristics Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 EBUS: endobronchial ultrasonography; EUS: endoscopic ultrasonography; pTNM: final pathology tumour, lymph node and metastatic classification. Table 1: Clinicopathological characteristics Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 EBUS: endobronchial ultrasonography; EUS: endoscopic ultrasonography; pTNM: final pathology tumour, lymph node and metastatic classification. RESULTS Final pathology after the initial surgery revealed lung cancer Stage Ia in 3 patients, Stage Ib in 9 patients and Stage IIIa in 2 patients, 1 patient with metastatic disease and 1 patient with benign disease (Table 1). In the 16 patients mentioned above, the CT scan showed enlarged tumours in the mediastinum (Fig. 1A). Endobronchial ultrasonography from different lymph node stations and from the enlargement in the mediastinum was performed, and smears and cellblocks were available for all 16 patients. In the smears, a high number of macrophages and amorphich extracellular material, which stained blue in the May-Gr� Giemsa (MGG) staining, were seen (Fig. 1B). Immunohistochemistry performed on the cellblock was positive for CD68 (macrophages marker) and negative for TTF-1, CK7 and P63/P40. There was no sign of lung cancer recurrence or other malignancies. One patient underwent reoperation by VATS 8 months after the initial VATS right upper lobectomy due to suspicion of recurrence in Station 7. Histology showed foreign body material. Figure 1: View largeDownload slide (A) A computed tomography scan of a 78-year-old man obtained 6 months after the right middle lobectomy showing an enlarged Station 7 lymph node (white arrow). Gelita-cel was used perioperatively for haemostasis. Endobronchial ultrasonography showed foreign body material with no sign of lung cancer. (B) MGG-stained smear showing a high number of macrophages and amorphich extracellular material. Figure 1: View largeDownload slide (A) A computed tomography scan of a 78-year-old man obtained 6 months after the right middle lobectomy showing an enlarged Station 7 lymph node (white arrow). Gelita-cel was used perioperatively for haemostasis. Endobronchial ultrasonography showed foreign body material with no sign of lung cancer. (B) MGG-stained smear showing a high number of macrophages and amorphich extracellular material. DISCUSSION Oxidized resorbable cellulose has been used in thoracic surgery, abdominal surgery and neurosurgery in the past decades. Using haemostatic agents is not risk free [1, 6]. In contrast to existing data and clinical reports, our observational data show that oxidized resorbable cellulose (Gelita-cel) was not reabsorbed as promised within 4 weeks [4, 6, 7]. Instead, the material remained as a foreign body material in the mediastinum, creating granulomas. Absorbable oxidized cellulose is the most commonly used haemostatic agent. Case reports on other types of oxidized absorbable cellulose (Surgicel) have been reported to be confused with an abscess after abdominal surgery [6]. In another occasion, it has caused foreign body reaction (gossypiboma) in abdominal surgery masking a recurrent ovarian cancer [10]. Paraplegia was observed due to intraspinal migration of a piece of Surgicel following cardiac surgery [6]. In an in vivo human observational study in Germany, 25 patients received cotton-derived oxidized cellulose (Gelita-cel) during thoracic surgery. They concluded that the cotton-derived oxidized cellulose was absorbed completely within 15 days [7]. In contrast to this study, we observed granulomas within the mediastinum after 4–60 months of control, with a median of 20 months with a minimum of 4.5 months and a maximum of 67 months. The short- and long-term complete resorption is important, especially in oncological patients, due to the risk of misdiagnosis of residual or recurrent tumour. Although all 200 patients have not been scanned yet, this still indicates a high risk (7.5%) of false positive diagnosis of cancer recurrence on CT follow-up and Gelita-cel has been removed from the surgical armamentarium in our department after the first case. With this, we highlight an issue not described in the literature earlier. We conclude that Gelita-cel has a high risk of causing foreign body material reaction in which the lymph node enlargement can be mistaken with a recurrence. Therefore, Gelita-cel should not be used as a haemostatic agent in thoracic surgery. Conflict of interest: none declared. REFERENCES 1 Peterffy A , Henze A. Haemorrhagic complications during pulmonary resection: a retrospective review of 1428 resections with 113 haemorrhagic episodes . Scand J Thorac Cardiovasc Surg 1983 ; 17 : 283 – 7 . Google Scholar CrossRef Search ADS PubMed 2 Paleru C , Marinescu L , Popescu V. Non-operative external fixation of flail chest using vacuum-assisted therapy . Interact CardioVasc Thorac Surg 2017 ; 25 . 3 Yim AP , Liu HP. Complications and failures of video-assisted thoracic surgery: experience from two centers in Asia . Ann Thorac Surg 1996 ; 61 : 538 – 41 . Google Scholar CrossRef Search ADS PubMed 4 Witte B , Kroeber SM , Hillebrand H , Wolf M , Huertgen M. Cotton-derived oxidized cellulose in minimally invasive thoracic surgery: a clinicopathological study . Innovations (Phila) 2013 ; 8 : 296 – 301 . Google Scholar CrossRef Search ADS PubMed 5 Bradely M , Singh G. Case report: an oxidized cellulose granuloma-another hepatic pseudotumour? Clin Radiol 1991 ; 44 : 206 – 7 . Google Scholar CrossRef Search ADS PubMed 6 Blair SD , Backhouse CM , Harper R , Matthews J , McCollum CN. Comparison of absorbable materials for surgical haemostasis . Br J Surg 1988 ; 75 : 969 – 71 . Google Scholar CrossRef Search ADS PubMed 7 http://www.gelitamedical.com/Products/Gelita-Cel (1 May 2018, date last accessed). 8 Hansen HJ , Petersen RH , Christensen M. Video-assisted thoracoscopic surgery (VATS) lobectomy using a standardized anterior approach . Surg Endosc 2011 ; 25 : 1263 – 91 . Google Scholar CrossRef Search ADS PubMed 9 Brodbelt AR , Miles JB , Foy PM , Joy PM. Intraspinal oxidised cellulose (Surgicel) causing delayed paraplegia after thoracotomy—a report of three case . Ann R Coll Surg Engl 2002 ; 84 : 97 – 9 . Google Scholar PubMed 10 Randolph BD , Virginia AL , Joel SN. Case report: foreign body reaction (gossypiboma) masking as recurrent ovarian cancer . Gynecol Oncol 1995 ; 56 : 94 – 6 . Google Scholar CrossRef Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Interactive CardioVascular and Thoracic Surgery Oxford University Press

Oxidized resorbable cellulose (Gelita-cel) causing foreign body reaction in the mediastinum

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Publisher
Oxford University Press
Copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
ISSN
1569-9293
eISSN
1569-9285
DOI
10.1093/icvts/ivy180
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Abstract

Abstract Different types of oxidized cellulose have been used for haemorrhage control in thoracic surgery, abdominal surgery and neurosurgery. Oxidized resorbable cellulose (Gelita-cel) is a new haemostatic agent. Once saturated with blood, it swells and makes a gelatinous mass that formats as a fibrin clot. We have performed a prospective observational cohort study of patients operated for lung cancer or suspected lung cancer using Gelita-cel as a haemostatic agent. Between October 2010 and April 2012, 477 patients were operated in our department for lung cancer. Gelita-cel was used in 200 patients due to minor intraoperative haemorrhage after lymph node resection from Stations 2 to 11. During follow-up for lung cancer, computed tomography, which was performed 4–60 months after the primary operation, showed enlarged lymph nodes in the mediastinum in 16 patients. Endoscopic bronchial ultrasonographic biopsies of the lymph nodes showed foreign body material and granulomatous inflammation, and no sign of lung cancer recurrence. Gelita-cel has a high risk of causing granuloma and should not be used as a haemostatic agent in thoracic surgery. Oxidized cellulose , Granuloma , Mediastinum , Haemostasis , Video-assisted thoracoscopic surgery INTRODUCTION Bleeding after pulmonary resection occurs approximately in 2% of patients after video-assisted thoracoscopic surgery (VATS) and in 1–3% of patients after thoracotomy [1–3]. Different types of oxidized cellulose have been used for haemorrhage control in thoracic surgery, abdominal surgery and neurosurgery. Absorbability and haemostatic effect of different oxidized cellulose has been compared in animals and humans [4–6] with different results. Oxidized resorbable cellulose (Gelita-cel, Gelita Medical, Germany) is a new haemostatic agent. ‘Once saturated with blood, it swells and makes a gelatinous mass that formats as a fibrin clot. It provides a strong matrix for platelet adhesion [7]. The product’s low pH causes localized vasoconstriction, further enhancing the haemostatic effect. In addition, the low pH exhibits antibacterial properties, minimizing the risk of infection’ [7]. It is extracted from natural alpha-grade cotton and is a 100% biodegradable organic material [7]. The oxidized cellulose degrades into oligosaccharides and creates an acidic environment that is a possible cause for anti-inflammatory and antiproliferative effect [4–6]. However, different studies and data show persisting deposits after inserting oxidized cellulose and were mistaken recurrent malignancies tumours and abscesses [9, 10]. PATIENTS AND METHODS We have performed a prospective observational cohort study of patients operated for lung cancer or suspected lung cancer in our department using a standardized anterior VATS approach [8]. Between October 2010 and April 2012, we operated on 477 patients. Gelita-cel was used in 200 patients due to minor intraoperative haemorrhage after lymph node dissection, mainly in the superior mediastinum (lymph node stations 2 and 4) or in the subcarinal area (lymph node station 7). Of these, we report on 16 patients who underwent VATS lobectomy n = 15 and wedge resection n = 1. The mean age of the patients was 60 years. Fourteen (87%) patients were smokers, 2 (13%) patients received anticoagulation therapy, which was stopped prior to surgery according to the guidelines. Positron emission tomography–computed tomography (PET-CT), CT and chest X-ray were performed prior to surgery in patients with suspected tumour. All patients were enrolled in a follow-up programme with CT of thorax and abdomen 4–60 months after the primary operation. Preoperatively, CT-guided samples from tumours were performed in 8 (50%) patients. Six patients were diagnosed with non-small-cell lung cancer and 2 had none of the representative materials. Six (37%) patients underwent preoperative endobronchial ultrasonography. The mean preoperative lung function was forced expiratory volume 2.09 and forced expiratory volume 68.9% ± standard deviation of the expected value (Table 1). The TNM Classification of Malignant Tumours was used as standard procedure to classify the tumours. VATS right upper lobectomy was performed in 8 (50%) patients and VATS middle lobe lobectomy in 1 (6%) patient. VATS left upper lobectomy was performed in 3 (19%) patients, 3 (19%) patients underwent VATS lower left lobectomy and 1 (6%) patient underwent VATS left upper wedge resection. Lymph node dissection with the removal of fatty tissue and lymph nodes was performed in Stations 2, 4 and 7–11 on the right side and in Stations 5–11 on the left side and were sent to the pathology department. PET scan was not taken postoperatively. Table 1: Clinicopathological characteristics Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 EBUS: endobronchial ultrasonography; EUS: endoscopic ultrasonography; pTNM: final pathology tumour, lymph node and metastatic classification. Table 1: Clinicopathological characteristics Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 Demographic data  Age (years), median (range) 60 (55–83)  Smoking   Non-smoker 2   Smokers 14 Oncological data  Laterality   Right side 9   Left side 7  Histology   Adenocarcinoma 12   Squamous cell carcinoma 2   Benign metastatic leiomyoma 1   Pulmonary fibrosis 1  Stage distribution (pTNM)   Stage Ia 3   Stage Ib 9   Stage IIIa 2  CT-guided biopsy (preoperative)   Metastatic 1   Benign 1   Adenocarcinoma 4   Squamous cell carcinoma 2   Not performed 8   Not representative material 2 Therapy data  EBUS/EUS preoperative   No malignant cells 5   Amorphous material 1   Not performed 11  EBUS/EUS postoperative   Foreign body materials 16  Type of surgery   Right upper lobectomy 8   Middle lobectomy 1   Left upper lobectomy 3   Left lower lobectomy 3   Left upper wedge resection 1 EBUS: endobronchial ultrasonography; EUS: endoscopic ultrasonography; pTNM: final pathology tumour, lymph node and metastatic classification. RESULTS Final pathology after the initial surgery revealed lung cancer Stage Ia in 3 patients, Stage Ib in 9 patients and Stage IIIa in 2 patients, 1 patient with metastatic disease and 1 patient with benign disease (Table 1). In the 16 patients mentioned above, the CT scan showed enlarged tumours in the mediastinum (Fig. 1A). Endobronchial ultrasonography from different lymph node stations and from the enlargement in the mediastinum was performed, and smears and cellblocks were available for all 16 patients. In the smears, a high number of macrophages and amorphich extracellular material, which stained blue in the May-Gr� Giemsa (MGG) staining, were seen (Fig. 1B). Immunohistochemistry performed on the cellblock was positive for CD68 (macrophages marker) and negative for TTF-1, CK7 and P63/P40. There was no sign of lung cancer recurrence or other malignancies. One patient underwent reoperation by VATS 8 months after the initial VATS right upper lobectomy due to suspicion of recurrence in Station 7. Histology showed foreign body material. Figure 1: View largeDownload slide (A) A computed tomography scan of a 78-year-old man obtained 6 months after the right middle lobectomy showing an enlarged Station 7 lymph node (white arrow). Gelita-cel was used perioperatively for haemostasis. Endobronchial ultrasonography showed foreign body material with no sign of lung cancer. (B) MGG-stained smear showing a high number of macrophages and amorphich extracellular material. Figure 1: View largeDownload slide (A) A computed tomography scan of a 78-year-old man obtained 6 months after the right middle lobectomy showing an enlarged Station 7 lymph node (white arrow). Gelita-cel was used perioperatively for haemostasis. Endobronchial ultrasonography showed foreign body material with no sign of lung cancer. (B) MGG-stained smear showing a high number of macrophages and amorphich extracellular material. DISCUSSION Oxidized resorbable cellulose has been used in thoracic surgery, abdominal surgery and neurosurgery in the past decades. Using haemostatic agents is not risk free [1, 6]. In contrast to existing data and clinical reports, our observational data show that oxidized resorbable cellulose (Gelita-cel) was not reabsorbed as promised within 4 weeks [4, 6, 7]. Instead, the material remained as a foreign body material in the mediastinum, creating granulomas. Absorbable oxidized cellulose is the most commonly used haemostatic agent. Case reports on other types of oxidized absorbable cellulose (Surgicel) have been reported to be confused with an abscess after abdominal surgery [6]. In another occasion, it has caused foreign body reaction (gossypiboma) in abdominal surgery masking a recurrent ovarian cancer [10]. Paraplegia was observed due to intraspinal migration of a piece of Surgicel following cardiac surgery [6]. In an in vivo human observational study in Germany, 25 patients received cotton-derived oxidized cellulose (Gelita-cel) during thoracic surgery. They concluded that the cotton-derived oxidized cellulose was absorbed completely within 15 days [7]. In contrast to this study, we observed granulomas within the mediastinum after 4–60 months of control, with a median of 20 months with a minimum of 4.5 months and a maximum of 67 months. The short- and long-term complete resorption is important, especially in oncological patients, due to the risk of misdiagnosis of residual or recurrent tumour. Although all 200 patients have not been scanned yet, this still indicates a high risk (7.5%) of false positive diagnosis of cancer recurrence on CT follow-up and Gelita-cel has been removed from the surgical armamentarium in our department after the first case. With this, we highlight an issue not described in the literature earlier. We conclude that Gelita-cel has a high risk of causing foreign body material reaction in which the lymph node enlargement can be mistaken with a recurrence. Therefore, Gelita-cel should not be used as a haemostatic agent in thoracic surgery. Conflict of interest: none declared. REFERENCES 1 Peterffy A , Henze A. Haemorrhagic complications during pulmonary resection: a retrospective review of 1428 resections with 113 haemorrhagic episodes . Scand J Thorac Cardiovasc Surg 1983 ; 17 : 283 – 7 . Google Scholar CrossRef Search ADS PubMed 2 Paleru C , Marinescu L , Popescu V. Non-operative external fixation of flail chest using vacuum-assisted therapy . Interact CardioVasc Thorac Surg 2017 ; 25 . 3 Yim AP , Liu HP. Complications and failures of video-assisted thoracic surgery: experience from two centers in Asia . Ann Thorac Surg 1996 ; 61 : 538 – 41 . Google Scholar CrossRef Search ADS PubMed 4 Witte B , Kroeber SM , Hillebrand H , Wolf M , Huertgen M. Cotton-derived oxidized cellulose in minimally invasive thoracic surgery: a clinicopathological study . Innovations (Phila) 2013 ; 8 : 296 – 301 . Google Scholar CrossRef Search ADS PubMed 5 Bradely M , Singh G. Case report: an oxidized cellulose granuloma-another hepatic pseudotumour? Clin Radiol 1991 ; 44 : 206 – 7 . Google Scholar CrossRef Search ADS PubMed 6 Blair SD , Backhouse CM , Harper R , Matthews J , McCollum CN. Comparison of absorbable materials for surgical haemostasis . Br J Surg 1988 ; 75 : 969 – 71 . Google Scholar CrossRef Search ADS PubMed 7 http://www.gelitamedical.com/Products/Gelita-Cel (1 May 2018, date last accessed). 8 Hansen HJ , Petersen RH , Christensen M. Video-assisted thoracoscopic surgery (VATS) lobectomy using a standardized anterior approach . Surg Endosc 2011 ; 25 : 1263 – 91 . Google Scholar CrossRef Search ADS PubMed 9 Brodbelt AR , Miles JB , Foy PM , Joy PM. Intraspinal oxidised cellulose (Surgicel) causing delayed paraplegia after thoracotomy—a report of three case . Ann R Coll Surg Engl 2002 ; 84 : 97 – 9 . Google Scholar PubMed 10 Randolph BD , Virginia AL , Joel SN. Case report: foreign body reaction (gossypiboma) masking as recurrent ovarian cancer . Gynecol Oncol 1995 ; 56 : 94 – 6 . Google Scholar CrossRef Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

Journal

Interactive CardioVascular and Thoracic SurgeryOxford University Press

Published: Jun 5, 2018

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