Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection
Background and study aims Submucosal (SM) injection is a critical step in endoscopic submucosal dissection (ESD). In Japan, use of viscous solutions such as sodium hyaluronate are recommended; the commercially product available is MucoUp (Seikagaku Co. and Boston Scientific Japan Co., Japan). Nevert...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Georg Thieme Verlag KG
2020-11-01
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| Series: | Endoscopy International Open |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/a-1265-6598 |
| _version_ | 1818640587613536256 |
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| author | Vitor Arantes Josue Aliaga Ramos Rafiz Abdul Rani Naohisa Yoshida |
| author_facet | Vitor Arantes Josue Aliaga Ramos Rafiz Abdul Rani Naohisa Yoshida |
| author_sort | Vitor Arantes |
| collection | DOAJ |
| description | Background and study aims Submucosal (SM) injection is a critical step in endoscopic submucosal dissection (ESD). In Japan, use of viscous solutions such as sodium hyaluronate are recommended; the commercially product available is MucoUp (Seikagaku Co. and Boston Scientific Japan Co., Japan). Nevertheless, MucoUp is expensive and unavailable in many Western countries. For the past 8 years, we have been using low-cost sterile teardrops solution composed of 0.4 % sodium hyaluronate (Adaptis Fresh, Legrand Laboratory, Brazil). This solution is readily available in drugstores with a cost of approximately US$ 10.00 for each 10-cc bottle. The aim of this study was to present the clinical outcome with off-label sodium hyaluronate use for SM injection in gastric ESD.
Patients and methods A single-center retrospective study of collected data investigating consecutive patients that underwent gastric ESD between 2012 and 2019. ESD was performed using 0.4 % sodium hyaluronate teardrop for SM injection and Flush Knife BT 2.5 (Fujifilm Co., Japan). The following data were analyzed: clinical-pathological features, en-bloc, R0 and curative resection rate, procedure duration, adverse events, and clinical outcome.
Results ESD was performed with sodium hyaluronate for submucosal injection in 78 patients. The en-bloc resection rate and R0 resection rate were 96.1 % and 92.3 %, respectively. The curative resection rate for epithelial lesions was 83.8 %. Adverse events occurred in 5 cases (6.3 %): delayed bleeding (3.8 %, 3 cases) and perforation (2.5 %, 2 cases); all managed successfully by clipping and thermal coagulation. The mean volume of sodium hyaluronate solution used per patient was 10 cc (SD: ± 8 cc). During follow-up (mean: 17 months; SD: ± 14.5 months), two patients developed metachronous lesions (2.5 %).
Conclusions Off-label use of teardrops with 0.4 % sodium hyaluronate for submucosal injection was demonstrated to be safe and able to provide an effective submucosal cushion that facilitates SM dissection in gastric ESD procedures. |
| first_indexed | 2024-12-16T23:13:39Z |
| format | Article |
| id | doaj.art-7f2ece28468b40d8a62ebd99217fc1a8 |
| institution | Directory Open Access Journal |
| issn | 2364-3722 2196-9736 |
| language | English |
| last_indexed | 2024-12-16T23:13:39Z |
| publishDate | 2020-11-01 |
| publisher | Georg Thieme Verlag KG |
| record_format | Article |
| series | Endoscopy International Open |
| spelling | doaj.art-7f2ece28468b40d8a62ebd99217fc1a82022-12-21T22:12:21ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362020-11-010812E1741E174710.1055/a-1265-6598Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissectionVitor Arantes0Josue Aliaga Ramos1Rafiz Abdul Rani2Naohisa Yoshida3Faculdade de Medicina da Universidade Federal de Minas Gerais – Alfa Institute of Gastroenterology, Minas Gerais, BrazilCayetano Heredia Pervuvian University, Lima, PeruUniversiti Teknologi MARA, Gastroenterology Unit, Faculty of Medicine,Selangor, MalaysiaKyoto Prefectural University of Medicine, Molecular Gastroenterology and Hepatology, Kyoto, JapanBackground and study aims Submucosal (SM) injection is a critical step in endoscopic submucosal dissection (ESD). In Japan, use of viscous solutions such as sodium hyaluronate are recommended; the commercially product available is MucoUp (Seikagaku Co. and Boston Scientific Japan Co., Japan). Nevertheless, MucoUp is expensive and unavailable in many Western countries. For the past 8 years, we have been using low-cost sterile teardrops solution composed of 0.4 % sodium hyaluronate (Adaptis Fresh, Legrand Laboratory, Brazil). This solution is readily available in drugstores with a cost of approximately US$ 10.00 for each 10-cc bottle. The aim of this study was to present the clinical outcome with off-label sodium hyaluronate use for SM injection in gastric ESD. Patients and methods A single-center retrospective study of collected data investigating consecutive patients that underwent gastric ESD between 2012 and 2019. ESD was performed using 0.4 % sodium hyaluronate teardrop for SM injection and Flush Knife BT 2.5 (Fujifilm Co., Japan). The following data were analyzed: clinical-pathological features, en-bloc, R0 and curative resection rate, procedure duration, adverse events, and clinical outcome. Results ESD was performed with sodium hyaluronate for submucosal injection in 78 patients. The en-bloc resection rate and R0 resection rate were 96.1 % and 92.3 %, respectively. The curative resection rate for epithelial lesions was 83.8 %. Adverse events occurred in 5 cases (6.3 %): delayed bleeding (3.8 %, 3 cases) and perforation (2.5 %, 2 cases); all managed successfully by clipping and thermal coagulation. The mean volume of sodium hyaluronate solution used per patient was 10 cc (SD: ± 8 cc). During follow-up (mean: 17 months; SD: ± 14.5 months), two patients developed metachronous lesions (2.5 %). Conclusions Off-label use of teardrops with 0.4 % sodium hyaluronate for submucosal injection was demonstrated to be safe and able to provide an effective submucosal cushion that facilitates SM dissection in gastric ESD procedures.http://www.thieme-connect.de/DOI/DOI?10.1055/a-1265-6598 |
| spellingShingle | Vitor Arantes Josue Aliaga Ramos Rafiz Abdul Rani Naohisa Yoshida Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection Endoscopy International Open |
| title | Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| title_full | Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| title_fullStr | Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| title_full_unstemmed | Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| title_short | Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| title_sort | off label use of 0 4 sodium hyaluronate teardrops a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/a-1265-6598 |
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