Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study
Endoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion for safe endoscopic resection. This study evaluated the safety and feasibility of a new injection solution (PuraLift) in ESD for early-stage gastrointestinal tumors. This prospective, single-arm, sin...
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| Format: | Article |
| Language: | English |
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Georg Thieme Verlag KG
2025-01-01
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| Series: | Endoscopy International Open |
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| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/a-2487-2823 |
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| author | Kengo Kasuga Keigo Sato Ko Nakata Hirohito Tanaka Hiroko Hosaka Shiko Kuribayashi Yoji Takeuchi Toshio Uraoka |
| author_facet | Kengo Kasuga Keigo Sato Ko Nakata Hirohito Tanaka Hiroko Hosaka Shiko Kuribayashi Yoji Takeuchi Toshio Uraoka |
| author_sort | Kengo Kasuga |
| collection | DOAJ |
| description | Endoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion for safe endoscopic resection. This study evaluated the safety and feasibility of a new injection solution (PuraLift) in ESD for early-stage gastrointestinal tumors. This prospective, single-arm, single-center pilot study included 11 patients with gastrointestinal neoplasms of the stomach (n = 5) or colorectum (n = 6) who underwent ESD. All patients underwent outpatient follow-up at week 4 to confirm presence or absence of adverse events (AEs). All underwent protocol treatment and post-treatment follow-up. None of the AEs were judged to have a cause-and-effect relationship with the study. Questionnaires to the operators who performed the protocol treatment and assistants who performed submucosal injections were evaluated in comparison with saline, and maintenance of mucosal lifting was long, comparable, and short (9/2/0). En bloc and R0 resections were achieved in all patients without intraprocedural AEs. Median size of the specimens was 40 mm (range, 20–70). Median excision time was 52 minutes (range, 22–130). Median volume of PuraLift was 32 mL (range, 22–130). No postoperative bleeding or delayed perforation was observed in any patient. The novel injectable material, PuraLift, can potentially ensure safe and feasible ESD. |
| format | Article |
| id | doaj-art-15899b44854144cb8e8153a231615dd8 |
| institution | Kabale University |
| issn | 2364-3722 2196-9736 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Georg Thieme Verlag KG |
| record_format | Article |
| series | Endoscopy International Open |
| spelling | doaj-art-15899b44854144cb8e8153a231615dd82025-01-14T00:02:50ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362025-01-011310.1055/a-2487-2823Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot studyKengo Kasuga0Keigo Sato1Ko Nakata2Hirohito Tanaka3Hiroko Hosaka4Shiko Kuribayashi5Yoji Takeuchi6https://orcid.org/0000-0003-3814-298XToshio Uraoka7https://orcid.org/0000-0002-4425-4331Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, JapanDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of MedicineEndoscopic submucosal dissection (ESD) requires an injection solution to create a submucosal cushion for safe endoscopic resection. This study evaluated the safety and feasibility of a new injection solution (PuraLift) in ESD for early-stage gastrointestinal tumors. This prospective, single-arm, single-center pilot study included 11 patients with gastrointestinal neoplasms of the stomach (n = 5) or colorectum (n = 6) who underwent ESD. All patients underwent outpatient follow-up at week 4 to confirm presence or absence of adverse events (AEs). All underwent protocol treatment and post-treatment follow-up. None of the AEs were judged to have a cause-and-effect relationship with the study. Questionnaires to the operators who performed the protocol treatment and assistants who performed submucosal injections were evaluated in comparison with saline, and maintenance of mucosal lifting was long, comparable, and short (9/2/0). En bloc and R0 resections were achieved in all patients without intraprocedural AEs. Median size of the specimens was 40 mm (range, 20–70). Median excision time was 52 minutes (range, 22–130). Median volume of PuraLift was 32 mL (range, 22–130). No postoperative bleeding or delayed perforation was observed in any patient. The novel injectable material, PuraLift, can potentially ensure safe and feasible ESD.http://www.thieme-connect.de/DOI/DOI?10.1055/a-2487-2823Endoscopy Upper GI TractEndoscopic resection (ESD, EMRc, ...)Endoscopy Lower GI TractEndoscopic resection (polypectomy, ESD, EMRc, ...) |
| spellingShingle | Kengo Kasuga Keigo Sato Ko Nakata Hirohito Tanaka Hiroko Hosaka Shiko Kuribayashi Yoji Takeuchi Toshio Uraoka Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study Endoscopy International Open Endoscopy Upper GI Tract Endoscopic resection (ESD, EMRc, ...) Endoscopy Lower GI Tract Endoscopic resection (polypectomy, ESD, EMRc, ...) |
| title | Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study |
| title_full | Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study |
| title_fullStr | Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study |
| title_full_unstemmed | Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study |
| title_short | Novel submucosal injection material comprising fully synthetic and self-assembling peptide solution in endoscopic submucosal dissection: A pilot study |
| title_sort | novel submucosal injection material comprising fully synthetic and self assembling peptide solution in endoscopic submucosal dissection a pilot study |
| topic | Endoscopy Upper GI Tract Endoscopic resection (ESD, EMRc, ...) Endoscopy Lower GI Tract Endoscopic resection (polypectomy, ESD, EMRc, ...) |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/a-2487-2823 |
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