Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 3.701
Filter
3.
J Assoc Physicians India ; 72(6): 97-98, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38881143

ABSTRACT

Many snakebite deaths in India may remain unreported as these patients still seek treatment from traditional healers or quacks. Though local and systemic toxicity due to snake envenomation is quite common, the clinical presentation as disseminated extensive tissue damage and ulceration is not seen. We present a lady who presented with extensive skin erosions with tissue necrosis in all four limbs and the trunk. The case was successfully managed with antisnake venom, wound debridement, and split skin grafting. Early antisnake venom halts the progression of tissue damage effects of snake venom. The future treatment of these extensive ulcerations may be the use of drugs that can inhibit the hydrolyzing enzymes of snake venom. The case also stresses the need for excellent wound care after the management of systemic envenomation with antivenom treatment.


Subject(s)
Antivenins , Snake Bites , Snake Bites/complications , Humans , Female , Antivenins/therapeutic use , Animals , Adult , Skin Transplantation/methods , Debridement/methods , Necrosis/etiology
5.
Cancer Radiother ; 28(3): 275-279, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38890033

ABSTRACT

Stereotactic body radiotherapy is a highly effective form of radiation therapy for palliation of bone metastases, but it can also lead to rare but severe side effects, such as myonecrosis. According to the literature, the incidence of myonecrosis after stereotactic body radiotherapy is low and mostly dose dependent. It is crucial to consider the potential impact of immunotherapy and other systemic therapies in the assessment. The course of radiation myonecrosis can vary, and corticosteroids or vascular endothelial growth factor inhibitors may potentially play a role in its treatment. Herein, we report two patients presenting with myonecrosis after stereotactic body radiotherapy for bone metastasis.


Subject(s)
Bone Neoplasms , Necrosis , Radiosurgery , Humans , Radiosurgery/adverse effects , Necrosis/etiology , Bone Neoplasms/secondary , Bone Neoplasms/radiotherapy , Male , Aged , Middle Aged , Female , Muscular Diseases/etiology , Radiation Injuries/etiology , Muscle, Skeletal/pathology
7.
J Plast Reconstr Aesthet Surg ; 94: 54-61, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38759512

ABSTRACT

BACKGROUND: Axillary and inguinal lymph node dissections are commonly associated with complications that often require additional interventions. METHODS: Patients who underwent axillary or inguinal lymphadenectomy via standard procedures were compared to an intervention cohort of patients who underwent axillary or inguinal lymphadenectomy with the use of topical tranexamic acid (TXA) to the wound cavity, a PICO (Smith&Nephew UK) closed-incision negative pressure dressing, and discharged early with a drain in-situ. RESULTS: Seventy-six patients in the control group (mean age 65.8 years, mean BMI 28.4 kg/m2) underwent open lymphadenectomy without topical TXA and a simple dressing. Seventy-eight patients were included in the intervention group (mean age 67.1 years, mean BMI 28.5 kg/m2). Patients in the intervention group had an inpatient stay of mean 5.6 days fewer than those in the control group (CI 3.09-5.31; p < .0001), an estimated saving to the healthcare trust of £ 3046.40 (US$3723.61) per patient in "bed days." They had longer drain duration (mean 15 days vs. 8.3 days); however, they had a statistically significant lower risk of seroma formation requiring drainage (6.4% vs. 21%; p = .009), and skin necrosis (0% vs. 6.6%; p = .027). They also had a lower risk of infection (17% vs. 29%), wound dehiscence (15% vs. 25%), and readmission (7.7% vs. 14%), although they were not statistically significant. Patients in the control group were more likely to receive antibiotics as inpatients (51% vs. 7.7%; p < .00001) and on discharge (24% vs. 5%; p < .0011) than those in the intervention group. CONCLUSIONS: Topical TXA, PICO dressing, and early discharge with a drain following lymphadenectomy results in a reduced rate of complications.


Subject(s)
Drainage , Lymph Node Excision , Necrosis , Negative-Pressure Wound Therapy , Postoperative Complications , Seroma , Tranexamic Acid , Humans , Seroma/prevention & control , Seroma/etiology , Seroma/epidemiology , Negative-Pressure Wound Therapy/methods , Female , Male , Aged , Tranexamic Acid/administration & dosage , Lymph Node Excision/adverse effects , Drainage/methods , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Necrosis/etiology , Administration, Topical , Antifibrinolytic Agents/administration & dosage , Axilla , Middle Aged , Skin/pathology , Length of Stay/statistics & numerical data , Incidence
8.
JBJS Case Connect ; 14(2)2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38758834

ABSTRACT

CASE: A 41-year-old man removed a tungsten carbide ring from his left index finger by cutting it off with a high-speed metal burr. The patient presented two days later with a pink and perfused left index finger with circumferential dry gangrene along the area of the ring, active flexor and extensor tendon excursion, and decreased sensation distally. Within 24 hours, the wound developed into wet gangrene and diffuse cyanosis requiring amputation. CONCLUSION: After reviewing previously documented methods to remove tungsten carbide rings, the authors conclude clinicians should be cognizant of the potential complications associated with the use of a high-speed metal burr.


Subject(s)
Amputation, Surgical , Tungsten Compounds , Humans , Male , Adult , Tungsten Compounds/adverse effects , Necrosis/etiology , Finger Injuries/surgery , Jewelry/adverse effects , Gangrene/etiology , Gangrene/surgery , Fingers/surgery
9.
World Neurosurg ; 186: e374-e381, 2024 06.
Article in English | MEDLINE | ID: mdl-38561029

ABSTRACT

BACKGROUND: Radiation necrosis (RN) after stereotactic radiosurgery (SRS) in brain metastases has been extensively evaluated, and RN is correlated with various risk factors. However, no study comprehensively analyzed the correlation between RN and the border zones of the brain that are vulnerable to ischemia. We hypothesized that patients with tumors in the border zone are at high risk of RN. Hence, the current study aimed to assess the correlation between border zone lesions and RN, with consideration of other predetermined factors. METHODS: This retrospective study included 117 patients with 290 lesions who underwent Gamma Knife SRS. Radiological and clinical analyses were performed to identify factors possibly correlated with RN. Notably, the lesion location was classified into 2 groups (border zone and nonborder zone) based on the blood supply. RESULTS: In total, 22 (18.8%) patients with 22 (7.5%) lesions developed RN. Univariate analysis revealed a significant correlation between RN and external border zone lesions, second course of SRS administered at the same site of the previous SRS, prescribed dose, and tumor volume. Multivariate analysis showed that border zone lesions, second course of SRS at the same site of the previous SRS, and tumor volume were significantly correlated with RN. CONCLUSIONS: Patients with tumors in the border zone are at high risk of RN. The potential risks of RN can be attributed hypothetically to hypoperfusion. Hence, the association between RN and border zone lesions seems reasonable.


Subject(s)
Brain Neoplasms , Necrosis , Radiation Injuries , Radiosurgery , Humans , Radiosurgery/adverse effects , Brain Neoplasms/secondary , Brain Neoplasms/radiotherapy , Female , Male , Middle Aged , Radiation Injuries/etiology , Radiation Injuries/pathology , Retrospective Studies , Necrosis/etiology , Aged , Adult , Aged, 80 and over , Risk Factors
10.
J Neurooncol ; 168(1): 1-11, 2024 May.
Article in English | MEDLINE | ID: mdl-38619777

ABSTRACT

PURPOSE: Radiation necrosis (RN) is a local inflammatory reaction that arises in response to radiation injury and may cause significant morbidity. This study aims to evaluate and compare the efficacy of bevacizumab and laser interstitial thermal therapy (LITT) in treating RN in patients with previously radiated central nervous system (CNS) neoplasms. METHODS: PubMed, Cochrane, Scopus, and EMBASE databases were screened. Studies of patients with radiation necrosis from primary or secondary brain tumors were included. Indirect meta-analysis with random-effect modeling was performed to compare clinical and radiological outcomes. RESULTS: Twenty-four studies were included with 210 patients in the bevacizumab group and 337 patients in the LITT group. Bevacizumab demonstrated symptomatic improvement/stability in 87.7% of cases, radiological improvement/stability in 86.2%, and steroid wean-off in 45%. LITT exhibited symptomatic improvement/stability in 71.2%, radiological improvement/stability in 64.7%, and steroid wean-off in 62.4%. Comparative analysis revealed statistically significant differences favoring bevacizumab in symptomatic improvement/stability (p = 0.02), while no significant differences were observed in radiological improvement/stability (p = 0.27) or steroid wean-off (p = 0.90). The rates of adverse reactions were 11.2% for bevacizumab and 14.9% for LITT (p = 0.66), with the majority being grade 2 or lower (72.2% for bevacizumab and 62.5% for LITT). CONCLUSION: Both bevacizumab and LITT exhibited favorable clinical and radiological outcomes in managing RN. Bevacizumab was found to be associated with better symptomatic control compared to LITT. Patient-, diagnosis- and lesion-related factors should be considered when choosing the ideal treatment modality for RN to enhance overall patient outcomes.


Subject(s)
Bevacizumab , Necrosis , Radiation Injuries , Humans , Bevacizumab/therapeutic use , Radiation Injuries/etiology , Radiation Injuries/drug therapy , Radiation Injuries/pathology , Necrosis/etiology , Laser Therapy/methods , Central Nervous System Neoplasms/radiotherapy , Central Nervous System Neoplasms/drug therapy , Central Nervous System Neoplasms/therapy , Antineoplastic Agents, Immunological/therapeutic use , Antineoplastic Agents, Immunological/adverse effects , Angiogenesis Inhibitors/therapeutic use
12.
BMC Musculoskelet Disord ; 25(1): 297, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38627691

ABSTRACT

BACKGROUND: The efficacy and safety of perforator-based propeller flaps (PPF) versus free flaps (FF) in traumatic lower leg and foot reconstructions are debated. PPFs are perceived as simpler due to advantages like avoiding microsurgery, but concerns about complications, such as flap congestion and necrosis, persist. This study aimed to compare outcomes of PPF and FF in trauma-related distal lower extremity soft tissue reconstruction. METHODS: We retrospectively studied 38 flaps in 33 patients who underwent lower leg and foot soft tissue reconstruction due to trauma at our hospital from 2015 until 2022. Flap-related outcomes and complications were compared between the PPF group (18 flaps in 15 patients) and the FF group (20 flaps in 18 patients). These included complete and partial flap necrosis, venous congestion, delayed osteomyelitis, and the coverage failure rate, defined as the need for secondary flaps due to flap necrosis. RESULTS: The coverage failure rate was 22% in the PPF group and 5% in the FF group, with complete necrosis observed in 11% of the PPF group and 5% of the FF group, and partial necrosis in 39% of the PPF group and 10% of the FF group, indicating no significant difference between the two groups. However, venous congestion was significantly higher in 72% of the PPF group compared to 10% of the FF group. Four PPFs and one FF required FF reconstruction due to implant/fracture exposure from necrosis. Additionally, four PPFs developed delayed osteomyelitis post-healing, requiring reconstruction using free vascularized bone graft in three out of four cases. CONCLUSIONS: Flap necrosis in traumatic lower-leg defects can lead to reconstructive failure, exposing implants or fractures and potentially causing catastrophic outcomes like osteomyelitis, jeopardizing limb salvage. Surgeons should be cautious about deeming PPFs as straightforward and microsurgery-free procedures, given the increased complication rates compared to FFs in traumatic reconstruction. DATA ACCESS STATEMENT: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.


Subject(s)
Foot Injuries , Fractures, Bone , Free Tissue Flaps , Hyperemia , Osteomyelitis , Soft Tissue Injuries , Humans , Leg , Retrospective Studies , Free Tissue Flaps/adverse effects , Hyperemia/complications , Lower Extremity/surgery , Fractures, Bone/surgery , Fractures, Bone/complications , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/surgery , Soft Tissue Injuries/surgery , Soft Tissue Injuries/complications , Osteomyelitis/surgery , Osteomyelitis/complications , Necrosis/etiology , Necrosis/surgery , Treatment Outcome
13.
BMJ Case Rep ; 17(4)2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38589239

ABSTRACT

A woman in her late 50s with a left frontal lobe convexity meningioma underwent an elective endovascular embolisation of the left middle meningeal artery and distal branches of the left superficial temporal artery prior to surgical resection of the tumour. On postoperative day 46, she developed scalp necrosis, leading to poor wound healing requiring wound debridement and a complex plastic surgery reconstruction with a rotational flap. Endovascular embolisation of vascular tumours prior to surgical resection does not come without risks. The lack of consistency in the literature regarding indication, technique and outcomes makes it difficult to define the exact role of preoperative meningioma embolisation.


Subject(s)
Meningeal Neoplasms , Meningioma , Female , Humans , Meningeal Neoplasms/diagnostic imaging , Meningeal Neoplasms/surgery , Meningioma/diagnostic imaging , Meningioma/surgery , Necrosis/etiology , Scalp/surgery , Temporal Arteries/diagnostic imaging , Temporal Arteries/surgery , Middle Aged
14.
Ann Plast Surg ; 92(4S Suppl 2): S179-S184, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38556670

ABSTRACT

PURPOSE: Nipple-areolar complex (NAC) viability remains a significant concern following prepectoral tissue expander (TE) reconstruction after nipple-sparing mastectomy (NSM). This study assesses the impact of intraoperative TE fill on NAC necrosis and identifies strategies for mitigating this risk. METHODS: A chart review of all consecutive, prepectoral TEs placed immediately after NSM was performed between March 2017 and December 2022 at a single center. Demographics, mastectomy weight, intraoperative TE fill, and complications were extracted for all patients. Partial NAC necrosis was defined as any thickness of skin loss including part of the NAC, whereas total NAC necrosis was defined as full-thickness skin loss involving the entirety of the NAC. P < 0.05 was considered statistically significant. RESULTS: Forty-six patients (83 breasts) with an average follow-up of 22 months were included. Women were on average 46 years old, nonsmoker (98%), and nondiabetic (100%) and had a body mass index of 23 kg/m2. All reconstructions were performed immediately following prophylactic mastectomies in 49% and therapeutic mastectomies in 51% of cases. Three breasts (4%) were radiated, and 15 patients (33%) received chemotherapy. Mean mastectomy weight was 346 ± 274 g, median intraoperative TE fill was 150 ± 225 mL, and median final TE fill was 350 ± 170 mL. Partial NAC necrosis occurred in 7 breasts (8%), and there were zero instances of complete NAC necrosis. On univariate analysis, partial NAC necrosis was not associated with any patient demographic or operative characteristics, including intraoperative TE fill. In multivariable models controlling for age, body mass index, mastectomy weight, prior breast surgery, and intraoperative TE fill, partial NAC necrosis was associated with lower body mass index (odds ratio, 0.53; confidence interval [CI], 0.29-0.98; P < 0.05) and higher mastectomy weight (odds ratio, 1.1; CI, 1.01-1.20; P < 0.05). Prior breast surgery approached significance, as those breasts had a 19.4 times higher odds of partial NAC necrosis (95% CI, 0.88-427.6; P = 0.06). CONCLUSIONS: Nipple-areolar complex necrosis following prepectoral TE reconstruction is a rare but serious complication. In this study of 83 breasts, 7 (8%) developed partial NAC necrosis, and all but one were able to be salvaged.


Subject(s)
Breast Neoplasms , Mammaplasty , Mastectomy, Subcutaneous , Female , Humans , Middle Aged , Mastectomy/adverse effects , Nipples/surgery , Breast Neoplasms/complications , Retrospective Studies , Mastectomy, Subcutaneous/adverse effects , Mammaplasty/adverse effects , Necrosis/etiology , Necrosis/prevention & control
15.
Medicina (B Aires) ; 84(2): 333-336, 2024.
Article in Spanish | MEDLINE | ID: mdl-38683519

ABSTRACT

Enteral nutrition through jejunostomy is a common practice in any general surgery service; it carries a low risk of complications and morbidity and mortality. We present the case of a patient with an immediate history of subtotal gastrectomy that began nutrition through jejunostomy and complicated with intestinal necrosis due to non-occlusive ischemia in the short period. The purpose of this work is to report on this complication, its pathophysiology and risk factors to take it into account and be able to take appropriate therapeutic action early.


La nutrición enteral por yeyunostomía es una práctica frecuente en cualquier servicio de cirugía general, esta conlleva bajo riesgo de complicaciones y morbimortalidad. Presentamos el caso de una paciente con antecedente inmediato de gastrectomía subtotal que inició nutrición por yeyunostomía y complicó con necrosis intestinal por isquemia no oclusiva en el corto lapso. La finalidad de este trabajo es informar sobre esta complicación, su fisiopatología y factores de riesgo para tenerla en cuenta y poder tomar precozmente una conducta terapéutica adecuada.


Subject(s)
Enteral Nutrition , Intestinal Perforation , Jejunostomy , Necrosis , Female , Humans , Middle Aged , Enteral Nutrition/adverse effects , Gastrectomy/adverse effects , Intestinal Perforation/etiology , Intestinal Perforation/surgery , Jejunostomy/adverse effects , Necrosis/etiology
16.
Pract Radiat Oncol ; 14(2): 87-92, 2024.
Article in English | MEDLINE | ID: mdl-38431371

ABSTRACT

Whole-brain radiation treatment is often considered for patients with leptomeningeal disease. There are limited reports of the development of radiation necrosis after whole-brain radiation treatment and fewer associating the presence of germline mutations with risk. We present a case report to highlight the need for consideration of radiosensitizing mutations when recommending radiation therapy.


Subject(s)
Brain Neoplasms , Humans , Brain Neoplasms/radiotherapy , Brain Neoplasms/complications , Cranial Irradiation/adverse effects , Brain/diagnostic imaging , Necrosis/etiology
17.
Clin J Gastroenterol ; 17(3): 563-566, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38430348

ABSTRACT

Fever, abdominal pain, and liver dysfunction are almost inevitable complications of transcatheter arterial chemo embolization (TACE) for hepatocellular carcinoma, but these symptoms may also be due to bile duct obstruction caused by shedding of necrotic tumor material into the bile duct. A 68-year-old man presented with persistent fever, liver dysfunction, and abdominal pain after TACE. Computed tomography revealed stone-like hyperdensities in the bile duct. Endoscopic retrograde cholangiopancreatography revealed these structures to be necrotic material from hepatocellular carcinoma. We believe this is an instructive case of an often overlooked situation.


Subject(s)
Carcinoma, Hepatocellular , Chemoembolization, Therapeutic , Liver Neoplasms , Necrosis , Humans , Male , Aged , Carcinoma, Hepatocellular/therapy , Carcinoma, Hepatocellular/pathology , Chemoembolization, Therapeutic/adverse effects , Liver Neoplasms/therapy , Liver Neoplasms/pathology , Liver Neoplasms/diagnostic imaging , Necrosis/etiology , Syndrome , Cholangiopancreatography, Endoscopic Retrograde , Tomography, X-Ray Computed
18.
Surg Endosc ; 38(4): 2148-2159, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38448625

ABSTRACT

BACKGROUND: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),ß but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS: gov, NCT03100578. RESULTS: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03100578.


Subject(s)
Drainage , Stents , Humans , Treatment Outcome , Stents/adverse effects , Drainage/methods , Length of Stay , Necrosis/etiology , Endosonography/methods
19.
Radiother Oncol ; 195: 110258, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38537680

ABSTRACT

This systematic review examines the role of dosimetric parameters in predicting temporal lobe necrosis (TLN) risk in nasopharyngeal carcinoma (NPC) patients treated with three-dimensional conformal RT (3D-CRT), intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT). TLN is a serious late complication that can adversely affect the quality of life of NPC patients. Understanding the relationship between dosimetric parameters and TLN can guide treatment planning and minimize radiation-related complications. A comprehensive search identified relevant studies published up to July 2023. Studies reporting on dosimetric parameters and TLN in NPC patients undergoing 3D-CRT, IMRT, and VMAT were included. TLN incidence, follow-up duration, and correlation with dosimetric parameters of the temporal lobe were analyzed. The review included 30 studies with median follow-up durations ranging from 28 to 110 months. The crude incidence of TLN varied from 2.3 % to 47.3 % and the average crude incidence of TLN is approximately 14 %. Dmax and D1cc emerged as potential predictors of TLN in 3D-CRT and IMRT-treated NPC patients. Threshold values of >72 Gy for Dmax and >62 Gy for D1cc were associated with increased TLN risk. However, other factors should also be considered, including host characteristics, tumor-specific features and therapeutic factors. In conclusion, this systematic review highlights the significance of dosimetric parameters, particularly Dmax and D1cc, in predicting TLN risk in NPC patients undergoing 3D-CRT, IMRT, and VMAT. The findings provide valuable insights that can help in developing optimal treatment planning strategies and contribute to the development of clinical guidelines in this field.


Subject(s)
Nasopharyngeal Carcinoma , Nasopharyngeal Neoplasms , Necrosis , Radiation Injuries , Radiotherapy, Intensity-Modulated , Temporal Lobe , Humans , Nasopharyngeal Carcinoma/radiotherapy , Nasopharyngeal Carcinoma/pathology , Temporal Lobe/radiation effects , Temporal Lobe/pathology , Necrosis/etiology , Radiation Injuries/etiology , Radiation Injuries/pathology , Nasopharyngeal Neoplasms/radiotherapy , Nasopharyngeal Neoplasms/pathology , Radiotherapy, Intensity-Modulated/adverse effects , Radiotherapy, Intensity-Modulated/methods , Radiotherapy Dosage , Radiotherapy, Conformal/adverse effects , Radiotherapy, Conformal/methods
20.
BMC Cancer ; 24(1): 332, 2024 Mar 12.
Article in English | MEDLINE | ID: mdl-38475765

ABSTRACT

BACKGROUND AND OBJECTIVES: Almost one third of cancer patients in the United States will develop brain metastases on an annual basis. Surgical resection is indicated in the setting of brain metastases for reasons, such as maximizing local control in select patients, decompression of mass effect, and/or tissue diagnosis. The current standard of care following resection of a brain metastasis has shifted from whole brain radiation therapy to post-operative stereotactic radiosurgery (SRS). However, there is a significant rate of local recurrence within one year of postoperative SRS. Emerging retrospective and prospective data suggest pre-operative SRS is a safe and potentially effective treatment paradigm for surgical brain metastases. This trial intends to determine, for patients with an indication for resection of a brain metastasis, whether there is an increase in the time to a composite endpoint of adverse outcomes; including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis - in patients who receive pre-operative SRS as compared to patients who receive post-operative SRS. METHODS: This randomized phase III clinical trial compares pre-operative with post-operative SRS for brain metastases. A dynamic random allocation procedure will allocate an equal number of patients to each arm: pre-operative SRS followed by surgery or surgery followed by post-operative SRS. EXPECTED OUTCOMES: If pre-operative SRS improves outcomes relative to post-operative SRS, this will establish pre-operative SRS as superior. If post-operative SRS proves superior to pre-operative SRS, it will remain a standard of care and halt the increasing utilization of pre-operative SRS. If there is no difference in pre- versus post-operative SRS, then pre-operative SRS may still be preferred, given patient convenience and the potential for a condensed timeline. DISCUSSION: Emerging retrospective and prospective data have demonstrated some benefits of pre-op SRS vs. post-op SRS. This study will show whether there is an increase in the time to the composite endpoint. Additionally, the study will compare overall survival; patient-reported outcomes; morbidity; completion of planned therapies; time to systemic therapy; time to regional progression; time to CNS progression; time to subsequent treatment; rate of radiation necrosis; rate of local recurrence; and rate of leptomeningeal disease. TRIAL REGISTRATION NUMBER: NCT03750227 (Registration date: 21/11/2018).


Subject(s)
Brain Neoplasms , Radiosurgery , Humans , Retrospective Studies , Radiosurgery/methods , Prospective Studies , Treatment Outcome , Brain Neoplasms/secondary , Necrosis/etiology , Randomized Controlled Trials as Topic , Clinical Trials, Phase III as Topic
SELECTION OF CITATIONS
SEARCH DETAIL
...