دورية أكاديمية
Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE)
| العنوان: | Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE) |
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| المؤلفون: | Hilal, Mohammed Abu, Kuemmerli, Christoph, Sijberden, Jasper P., Moekotte, Alma, Zimmitti, Giuseppe, Alseidi, Adnan, Asbun, Horacio J., Marudanayagam, Ravi, Bonds, Morgan, Kunzler, Filipe, Sutcliffe, Robert, Eren, Efrem, Primrose, John N., Williams, Anthony P. |
| سنة النشر: | 2024 |
| المجموعة: | University of Southampton: e-Prints Soton |
| الوصف: | Background: the spleen plays a significant role in the clearance of circulating microorganisms. Sequelae of splenectomy, especially immunodeficiency, can have a deleterious effect on a patient's health and even lead to death. Hence, splenectomy should be avoided and spleen preservation during elective surgery has become a treatment goal. However, this cannot be achieved in every patient due to intraoperative technical difficulties or oncological reasons. Autogenic splenic implantation (ASI) is currently the only possible way to preserve splenic function when a splenectomy is necessary. Experience largely stems from trauma patients with a splenic rupture. Splenic immune function can be measured by the body's clearing capacity of encapsulated bacteria. The aim of this study is to assess the splenic immune function after ASI was performed during minimally invasive (laparoscopic or robotic) distal pancreatectomy with splenectomy. Methods: this is the protocol for a multicentre, randomized, open-labelled trial. Thirty participants with benign or low-grade malignant lesions of the distal pancreas requiring minimally invasive distal pancreatectomy and splenectomy will be allocated to either additional intraoperative ASI (intervention) or no further intervention (control). An additional 15 patients who will undergo spleen-preserving distal pancreatectomy serve as the control group with normal splenic function. Six months postoperatively, after assumed restoration of splenic function, patients will be given a Salmonella typhi (Typhim Vi™) vaccine. The Salmonella typhi vaccine is a polysaccharide vaccine. The specific antibody titres immediately before and 4 to 6 weeks after vaccination will be measured. The ratio between pre- and post-vaccination antibody count is the primary outcome measure and secondary outcome measures include intraoperative details, length of hospital stay, 30-day mortality and morbidity. Discussion: this study will investigate the splenic immune function of patients who undergo ASI during minimally ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| العلاقة: | https://eprints.soton.ac.uk/486472/1/s13063_023_07714_1.pdfTest; Hilal, Mohammed Abu, Kuemmerli, Christoph, Sijberden, Jasper P., Moekotte, Alma, Zimmitti, Giuseppe, Alseidi, Adnan, Asbun, Horacio J., Marudanayagam, Ravi, Bonds, Morgan, Kunzler, Filipe, Sutcliffe, Robert, Eren, Efrem, Primrose, John N. and Williams, Anthony P. (2024) Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE). Trials, 25 (1), [31]. (doi:10.1186/s13063-023-07714-1 ). |
| الإتاحة: | https://doi.org/10.1186/s13063-023-07714-1Test https://eprints.soton.ac.uk/486472Test/ https://eprints.soton.ac.uk/486472/1/s13063_023_07714_1.pdfTest |
| حقوق: | cc_by_4 |
| رقم الانضمام: | edsbas.E3F39C76 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |