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Conservation therapy for breast cancers other than infiltrating ductal carcinoma.

Pathologic review of 861 Stage I and II breast cancers yielded 152 patients (18%) with histologic types other than invasive ductal carcinoma. All patients had been treated by breast-conserving surgery and radiotherapy, including supplemental radiation to the tumor bed. For 67 patients with predominantly lobular carcinomas, the actuarial overall 5-year survival was 100% and 77% for node-negative and node-positive patients, respectively. The actuarial probability of recurrence in the treated breast (13.5% at 5 years) appeared to be somewhat greater than that observed after treatment of invasive ductal cancers (8.8% at 5 years, P = 0.11). Of 12 mammary recurrences in patients with lobular carcinoma, four occurred at a considerable distance from the original primary and seven were multifocal, involving more than one quadrant in five patients. Of 47 patients with strictly in situ carcinomas, one patient whose axillary nodal status had not been determined subsequently developed distant metastases. Three additional patients developed mammary recurrence, two at the primary tumor site and one in another quadrant. The actuarial 5-year mammary recurrence and overall survival rates were 4% and 98%, respectively. For 27 patients with true medullary cancers, overall survival at 5 years was 90%. One localized mammary recurrence was observed at the site of the original primary. Actuarial mammary recurrence rate was 4% at 5 years. No relapse was observed in ten patients with colloid and one patient with adenoid cystic carcinoma. The authors conclude that, in addition to its well-established efficacy in the treatment of infiltrating ductal carcinomas, the combination of tumor excision and radiotherapy appears to provide adequate local control for other histologic types as well. However, patients with lobular cancer appear to be at somewhat greater risk of mammary failure, and recurrences in such patients tend to be multifocal and multicentric.

Adenocarcinoma, Mucinous↗

Orthotopic liver transplantation in human immunodeficiency virus (HIV)-positive patients: outcome of 7 patients from the Bonn cohort.

The outcome and clinical features of 7 HIV-positive patients who were liver transplanted at Bonn University in the era of highly active antiretroviral therapy (HAART) between 1997 and 2004, analyzed by retrospective chart review, are reported. Reasons for orthotopic liver transplantation (OLT) were end-stage liver disease due to chronic hepatitis C (n = 4) or hepatitis B (n = 1) or acute liver failure due to fulminant hepatitis B (n = 2). Immunosuppression was based on cyclosporine A and prednisone. HAART was reinitiated 1 month after transplantation, and immunosuppression was carefully adapted to account for drug-drug interactions between cyclosporine A and protease inihibitors. Prednisone was withdrawn 5 months (median) after OLT when immunosuppression had been reliably established in the presence of HAART. One patient died 95 days after OLT due intrathoracic hemorrhage, whereas 6 patients were alive at a median of 24 months. A single episode of acute rejection was observed. The spectrum of postoperative complications was no different from HIV-negative patients apart from Kaposi's sarcoma and multicentric Castleman's disease in a single patient. Recurrent hepatitis B infection was efficiently prevented, whereas hepatitis C reinfection occurred in all 4 patients who had preexisting hepatitis C. Earlier reports on fatal courses of recurrent hepatitis C infection, high rates of organ rejection, and HAART-related liver toxicity were not observed in our patients. In conclusion, even though preliminary, our data suggest that outcomes after liver transplantation of HIV-infected patients can be improved.

Adult↗

Total laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial.

PURPOSE: Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH). METHODS: Patient recruitment was designed to proceed along two stages to accommodate for a potential increase in patient requests of laparoscopic surgery. During the first stage, patients are randomised in a 2:1 allocation to receive TLH or TAH, with the primary endpoint quality of life (QoL) at 6 month post-surgery, requiring 180 patients to be enrolled to have 80% power at alpha=0.05 to detect a clinically significant difference of 8 points on the Functional Assessment of Cancer General (FACT-G) QoL instrument. If additional recruitment of patients seems impossible after accrual of 180 patients, this cohort will be followed for 4 years, and disease free survival (DFS) of patients treated by TLH will be compared to DFS within the endometrial cancer population. During the second stage, recruitment will be extended to a total of 590 patients in a 1:1 TLH:TAH allocation, to assess the equivalence with respect to DFS with 80% power and alpha=0.05. Equivalence will be assumed if the difference in DFS does not exceed 7% at 4 years. Secondary outcomes include treatment related morbidity; costs and cost-effectiveness; patterns of recurrence; and overall survival. All data from this multicentre study will be entered using online electronic case report forms (e-CRF), allowing real time assessment of data completeness and patient follow-up. CONCLUSIONS: The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.

Adenocarcinoma↗

Duct carcinoma in situ: 227 cases without microinvasion.

From 1979 to 1990, 227 patients with intraductal carcinomas (DCIS) without microinvasion were selectively treated; the least favourable (large lesions with involved biopsy margins) with mastectomy, the most favourable (small lesions with clear margins) with breast preservation. The preservation group was further subdivided into those who received radiation therapy (excision and radiation) and those who did not (excision alone). In the mastectomy group, there were 98 patients (43%) with an average lesional size of 3.3 cm; 41% had multifocal lesions, 15% had multicentric lesions. There has been one local invasive recurrence and no deaths. The 7-year actuarial disease-free survival is 98% with mastectomy. In the excision and radiation group, there were 103 patients (45%) with an average lesional size of 1.4 cm. 10 patients have had local recurrences (5 invasive and 5 noninvasive) one of whom has died. The 7-year actuarial disease-free survival is 84%, a statistically significant difference when excision and radiation is compared with mastectomy (P = 0.038). In the excision alone group, there were 26 patients (11%) with an average lesional size of 1.0 cm. There have been two local recurrences (8%), one of which was invasive and no deaths. The 7-year actuarial disease-free survival is 67%, but only 3 patients have been followed for more than 4 years. A total of 163 axillary node dissections were done; all were negative. Since DCIS without microinvasion rarely metastasizes to axillary lymph nodes, routine dissection should not be performed. Patients in this series with intraductal carcinoma treated with excision and radiation recurred locally at a statistically higher rate than those treated with mastectomy, in spite of the fact that those chosen for excision and radiation had clinically more favourable lesions. 6 of 12 (50%) local recurrences in conservatively treated patients were invasive. There was, however, no significant difference in overall survival in any subgroup regardless of treatment.

Adult↗

Long-term evaluation following resection of apparently benign pheochromocytoma(s)/paraganglioma(s).

In the absence of distant disease, the pathologic diagnosis of malignancy in pheochromocytoma or paraganglioma is impossible. In an effort to establish the true incidence of recurrence in this disease, we have analyzed long-term follow-up (average, 15.8 years) of 98 patients who underwent complete resection of localized, noninvasive, histologically-benign pheochromocytomas and paragangliomas at our institution between 1960 and 1976. Eighty-eight patients had nonfamilial, sporadic pheochromocytoma/paraganglioma. Nine had multiple endocrine neoplasia (MEN) type 2 (2A: 7, 2B: 2), and 1 had familial pheochromocytoma. Seventy-nine patients had single pheochromocytomas; 10 had single extraadrenal tumors (paragangliomas); and 9 had multicentric or bilateral adrenal tumors. Six patients (6.5%) developed recurrent pheochromocytoma after documentation of normal postoperative urinary catecholamine levels. One of these patients had MEN 2A. The recurrences developed at intervals from 5 to 13 years following initial resection. These were distant in 3 patients, local in 2, and both local and distant in a single patient. None of the recurrences occurred in the 13 patients who, on pathologic rereview, had either local or vascular invasion. No paraganglioma recurred. Life-long follow-up of all patients who have had pheochromocytomas or paragangliomas resected is mandatory.

Adolescent↗

Oral mesalazine (5-aminosalicylic acid; Asacol) for the prevention of post-operative recurrence of Crohn's disease. Gruppo Italiano per lo Studio del Colon e del Retto (GISC).

METHODS: A multicentre randomized controlled trial was conducted to evaluate the efficacy of oral mesalazine (5-aminosalicylic acid) for the prevention of post-operative recurrence in 110 patients operated on for Crohn's disease by first intestinal resection. Patients were randomly allocated to receive 2.4 g/day of mesalazine, or no treatment at all. The protocol included colonoscopy with ileoscopy at 6 months and yearly thereafter. Recurrence was defined on the basis of endoscopic criteria and classified as mild or severe. RESULTS: The demographic and pre-trial characteristics were very similar in the two groups of patients. The cumulative proportion of recurrence at 6, 12 and 24 months was significantly lower in the mesalazine group than in untreated group (P = 0.002). At 24 months the cumulative proportions of endoscopic recurrence were 0.52 +/- 0.12 (+/- S.E.M.) and 0.85 (+/- 0.07), respectively. At the same time the cumulative proportions of symptomatic recurrence were 0.18 +/- 0.09 and 0.41 +/- 0.09 (P = 0.006). The cumulative proportions of the severe recurrence was also significantly lower in the mesalazine group (0.17 +/- 0.09 vs. 0.38 +/- 0.09; P = 0.021). CONCLUSIONS: The preliminary results of this study show that administration of oral mesalazine soon after surgery is effective in preventing post-operative endoscopic recurrence in Crohn's disease over a 2-year period. It is estimated that this treatment prevents 39% of all recurrences and 55% of the severe recurrences.

Administration, Oral↗

Role of adjuvant treatment in liver transplantation for advanced hepatocellular carcinoma.

The results of liver transplantation for advanced hepatocellular carcinoma have been disappointing because of high recurrence rates, leading to low long-term survival; this indication remains controversial in an era of organ shortage. To continue to offer this treatment possibility, efforts were made to reduce recurrence and improve survival. The first approach is to maintain a strict selection policy excluding patients with extraheptic disease. The second approach is to test the efficacy of perioperative adjuvant therapies in patients selected for transplantation. The reasons for recurrence include: (1) undetected preoperative micrometastases, (2) intraoperative dissemination by surgical manipulation, and (3) acceleration of tumor growth by immunosuppression. Preoperative treatment, which may include systemic chemotherapy or arterial chemoembolization, seems necessary to limit tumor progression during the waiting period. Systemic chemotherapy has been tested pre-, intra-, and postoperatively. It is considered essential postoperatively and should be used as soon as possible after surgery (i.e., in the 1st postoperative week). Several teams have performed pilot studies that included rather limited numbers of patients, and the results were compared with those for historic controls. Published results show that chemoembolization creates tumor necrosis in most instances. This is efficient in limiting tumor progression but the effect on recurrence and survival is unknown. All authors who used postoperative chemotherapy reported improved survival over controls, with 50%-60% 3-year survival and up to 50% 5-year survival. However, recent results suggest that late recurrence may occur. Chemotherapy was usually well tolerated, although leukopenia, sometimes severe, was observed in most patients. The use of granulocyte colony-stimulating factor seems useful to overcome this problem. Perioperative adjuvant treatments seem to prolong survival in patients undergoing liver transplantation for advanced hepatocellular carcinoma, but delayed recurrence remains possible. Further studies are necessary; these should ideally be multicentric, prospective, and randomized.

Carcinoma, Hepatocellular↗

Phase II study of D.651, an oral vaccine designed to prevent recurrences of vulvovaginal candidiasis.

A vaccine has been prepared with ribosomes of Candida albicans serotypes a and b plus, as adjuvant, membrane proteoglycan from a nonencapsulated Klebsiella pneumoniae. A preliminary phase II trial without placebo control was conducted in 22 women with a history of frequent recurrences of vulvovaginal candidiasis (VVC). Initially, all the patients were treated locally with an antimycotic cream. Beginning at the same time, vaccine was taken orally in capsules containing 0.55 microgram active components. It was administered intermittently over six months, groups of women taking doses of two, three, six or nine capsules. Tolerance was excellent except for mild nausea, probably due to the excipients, in two patients taking nine capsules. Twenty patients completed the study. Only seven of them had a documented recurrence of VVC during the 6 months on vaccine. No recurrence occurred in the eight women taking six or nine capsules per day. Before the study, these 20 patients had had an average of 3.59 attacks of VVC per 6 months. On vaccine, the average rate of recurrence was only 0.55 attacks per 6 months. A multicentre placebo-controlled study of the efficacy of this vaccine is in progress to validate these encouraging preliminary results.

Administration, Oral↗

Influence of sialomucin at the resection margin on local tumour recurrence and survival of patients with colorectal cancer: a multivariate analysis.

In a multicentre prospective trial 358 patients undergoing curative surgery for colorectal cancer were followed for a median 18.0 months (+/- 7.2 months). The presence or absence of sialomucin in either resection margin was studied using the high iron diamine-alcian blue stain. There was evidence of excess sialomucin at one or other resection margin in 106 patients (29.6 per cent). Apart from sigmoid carcinomas occurring more often in the sialomucin positive group, there were no significant differences in any histological or clinical parameters between groups. Survival analysis for the events 'death', 'local recurrence', and 'all recurrence' was undertaken using the Cox regression model. The best prognostic variables selected in a stepwise fashion for death and all recurrence were 'Dukes' classification', 'sialomucin present' and 'histological differentiation'. The best prognostic variables selected for local recurrence were 'sialomucin present', 'Dukes' classification' and 'histological differentiation'. Sialomucin in a resection margin is an important independent prognostic variable for the development of local tumour recurrence and of subsequent survival for patients with colorectal carcinoma.

Aged↗

Recurrent adult myofibromatosis. A case report.

Myofibromatosis generally is regarded as a fibrous proliferative disease of neonates and children that, even when multicentric, has an excellent prognosis and a propensity for spontaneous involution. Reported is a case of solitary, locally recurrent myofibromatosis in the ear canal of an adult patient. It was initially thought to be a leiomyoma. The diagnosis of myofibromatosis was made on the basis of its histologic appearance and corroborated by immunohistochemical stains. Clinicians and pathologists should be aware that myofibromatosis may occur in adults in unusual locations, with a potential for local recurrence. Furthermore, its histologic appearance may mimic that of other mesenchymal neoplasms.

Adult↗

[Treatment of uncomplicated recurrent cystitis in women: lomefloxacin versus norfloxacin].

OBJECTIVE: compare the acceptability of 3-day regimen with that of 10-day regimen of fluoroquinolones for the treatment of recurrent uncomplicated lower urinary tract infection in women. METHODS: a multicentric, randomized open trial was conduced in 421 patients by gynecologic and general practitioners to determine acceptability, efficacy and safety of lomefloxacin 400 mg in a once a day dose given for three days compared with norfloxacin 800 mg in twice a day dose given for ten days for the treatment of recurrent uncomplicated lower urinary tract infection in women. RESULTS: acceptability, assessed at day 14, was significantly better for lomefloxacin group than norfloxacin group, respectively 57,1 p.100 and 38,0 p.100. Clinical success rate at day 14 was 97,2 p.100 for lomefloxacin and 97,5 p.100 for norfloxacin; at day 30 clinical success rate was respectively 97,6 p.100 and 98,1 p.100 relapse at one year was comparable between two groups. Adverse events were reported respectively in 15,6 p.100 and 16,6 p.100 of the patients, vaginal infections, dermatologic disorders and digestive disorders (abdominal pain, nausea) predominated. There were no serious adverse event. CONCLUSION: the acceptability is better for a 3-day regimen of lomefloxacin than a 10-day regimen of norfloxacin for treatment of recurrent uncomplicated lower urinary tract infection in women for comparable efficacy and safety.

Adult↗

Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma.

BACKGROUND: Monoclonal antibodies are being utilized for treatment of patients with low-grade non-Hodgkin's lymphoma as well as other cancers. Results from phase I and II clinical studies has shown that the chimeric monoclonal antibody Rituximab has minimal toxicity and significant therapeutic activity in low grade non-Hodgkin's lymphoma. PATIENTS AND METHODS: We have recently reported on a multicentre pivotal phase III clinical trial involving 166 patients with recurrent low-grade lymphoma who were treated with four infusions of Rituximab. Eighty patients (48%) achieved objective responses including 10 patients (6%) with complete responses. Overall, 126 patients (76%) had a > or = 20% reduction in overall tumor size. The median response duration and time to progression are 11.6 and 13.2 months, respectively. The infusional and long term toxicities were limited. RESULTS: In this report we describe the pharmacokinetic data obtained on these patients. Measurable concentrations of Rituximab were detected in all patients after the first infusion and increased throughout the treatment course. The half-life of the monoclonal antibody increased from 76.3 hours after the first infusion to 205.8 hours after the fourth infusion and was concomitant with a four-fold decrease in the antibody clearance. At three months and six months post-treatment, the median Rituximab serum levels were 20.3 micrograms/ml (range 0.0 to 96.8 micrograms/ml in 104 patients) and 1.3 micrograms/ml (range 0.0-28.7 micrograms/ml in 13 patients), respectively. A statistically significant correlation was found between the median antibody concentration and response for multiple time points during the treatment and followup. The mean serum antibody concentration was also inversely correlated with measurements of tumor bulk and with the number of circulating B cells at baseline. CONCLUSIONS: We conclude that Rituximab is therapeutically effective against B-cell lymphoma. Pharmacokinetic data suggests that certain subsets of patients may possibly benefit from increased dosing and studies to address this are currently underway.

Antibodies, Monoclonal↗

Strategies in the prevention of post-operative recurrence in Crohn's disease.

The majority of patients with Crohn's disease require resectional surgery in the course of their disease. Most of them will suffer symptomatic recurrence in the years after their operation, leading to new complications and sometimes repeated surgery. Clinical risk factors for early and evolutive recurrence have not been well identified. Smoking, perforating behaviour of the disease and ileal or ileocolonic location seem to predispose to early and aggressive recurrence. No clear prophylactic drug regime has been identified. Sulfasalazine and 5-ASA are only mildly protective and meta-analysis of all studies does not show superiority over placebo. Glucocorticosteroids are not efficacious. Nitroimidazole antibiotics, metronidazole and ornidazole prevent early endoscopic recurrence and postpone symptomatic relapse but are not well tolerated. Immunosuppression with azathioprine or 6-MP is attractive but hard data concerning their efficacy are still lacking. No data are available on the use of biologicals for the prevention of post-operative Crohn's disease. We need well designed and well powered multicentre trials to investigate the efficacy of different drugs for recurrence prophylaxis.

Adjuvants, Immunologic↗

Conservative management of hyperplastic and multicentric nephroblastomatosis.

PURPOSE: The treatment of hyperplastic nephroblastomatosis remains controversial. We report the advantages of conservative management of hyperplastic and multicentric nephroblastomatosis associated with unilateral Wilms tumor (WT). MATERIALS AND METHODS: During the last 10 years 48 children with unilateral WT were consecutively treated at our 2 institutions. Children with multiple solid renal masses on imaging were treated with 2-drug chemotherapy until disappearance of the lesions. Stabilization or progression of the lesions despite chemotherapy, as well as heterogeneity of the lesions on imaging, prompted nephron sparing surgery (NSS). RESULTS: Three female infants (12, 13 and 20 months old, respectively) presented with multiple solid renal tumors at imaging. Despite chemotherapy, small and unilateral WT developed in 2 cases of hyperplastic nephroblastomatosis, which was excised. One of these infants subsequently presented with a small contralateral metachronous WT, which was excised. Both infants are disease-free with 2 normal kidneys at followup of 6 and 2 years, respectively. The third infant, who presented with unilateral multicentric WT and unilateral hyperplastic nephroblastomatosis nodules, was successfully treated with preoperative chemotherapy and enucleation of 5 tumors. Subsequently, nephrectomy was performed at another institution because the abnormal kidney outline due to NSS was misinterpreted as a recurrence of WT. She was lost to followup. CONCLUSIONS: Hyperplastic and multicentric nephroblastomatosis is not a rare lesion and is most often associated, either initially or subsequently, with WT. In some infants with multiple solid renal masses on imaging chemotherapy and for developing WT NSS may safely allow maximum sparing of the parenchyma of both kidneys.

Antineoplastic Combined Chemotherapy Protocols↗

Recurrent hepatocellular carcinoma after spontaneous regression.

The prognosis of untreated hepatocellular carcinoma (HCC) is usually grave, although there have been a few case reports of spontaneous regression. Tumor recurrence after spontaneous regression has been rarely reported, and there have been no previous reports of recurrent hepatocellular carcinoma after spontaneous regression. Two cases of hepatocellular carcinoma that spontaneously regressed and subsequently recurred are presented. The patients' tumors spontaneously regressed, as reflected by the radiologically evidenced reduction in tumor size and markedly decreased alpha-fetoprotein levels. Subsequent tumor recurrences after regression were evidenced by radiologic findings of newly growing nodules and appreciably increased alpha-fetoprotein levels. To the authors' knowledge, these two patients represent the first reported cases of hepatocellular carcinoma recurrence after spontaneous regression. In both of these patients, new hepatocellular carcinomas recurred at different sites before the spontaneous regression of the original HCCs was complete. Although the precise causes of the regression and the subsequent recurrence remain to be further investigated, this phenomenon suggests that multicentric hepatocarcinogenicity and intratumoral events in each hepatocellular carcinoma nodule may be involved.

Adult↗

Repeat breast-conserving surgery for in-breast local breast carcinoma recurrence: the potential role of partial breast irradiation.

Mastectomy is the current standard of care for in-breast local recurrence of breast carcinoma. The objective of the current study was to critically review the rationale for and the theoretic and actual risks and benefits of repeat breast-conserving surgery followed by partial breast irradiation (PBI) for in-breast local recurrence of breast carcinoma. The main outcomes of interest were local control and survival after in-breast local recurrence and side effects, complications, and cosmesis after reirradiation of the breast. The risk of local recurrence was not found to be eliminated with mastectomy; approximately 2-32% of patients treated with mastectomy develop a chest wall recurrence. The interpretation of local control rates in evaluating repeat breast-conserving surgery studies is difficult because of the lack of information regarding preoperative diagnostic mammography to rule out concurrent multicentric disease and microscopic margin status after surgery. Rates of subsequent local recurrence in these studies appeared to be between 19-50%, similar to reported rates of in-breast local recurrence in patients with a first diagnosis of breast carcinoma who were treated with conservative surgery without irradiation. Early follow-up studies of breast reirradiation suggest that catheter-based interstitial brachytherapy and standard external beam radiation therapy can be delivered to the breast more than once without significant side effects in most patients and with acceptable cosmesis in some patients. Mastectomy may not be necessary in all patients with an in-breast local recurrence of breast carcinoma. Recent advances in conformal radiation delivery and single-center published reports concerning repeat breast-conserving therapy support well designed prospective trials to formally test this hypothesis.

Breast Neoplasms↗

Management of local recurrence in well-differentiated thyroid carcinoma.

Local recurrence of well-differentiated thyroid carcinoma has a reported mortality approaching 50%. The University of Kentucky experience was reviewed to determine whether aggressive surveillance and treatment with reoperation and/or I-131 ablation increased survival following recurrence. Records of 66 consecutive patients with well-differentiated thyroid carcinoma treated at the University of Kentucky Medical Center (1980-1989) were reviewed. Forty-nine cases of papillary carcinoma and 17 cases of follicular carcinoma were studied; median follow-up was 68 months. At presentation, patients with follicular carcinoma were older (48 versus 35 years; P less than 0.05) and more frequently had metastatic disease (17% versus 2%, P less than 0.05). Fifty-eight (88%) patients were alive and disease-free at last follow-up. Fifteen patients (24%) had developed recurrent disease; median time to recurrence was 24 months. Multivariate regression examined the variables of age, sex, histology, tumor size, cervical adenopathy, capsular and vascular invasion, multicentricity, and surgical procedure. While distant metastases affected actuarial survival, no factor independently predicted local recurrence. In six patients with local recurrence, nonpalpable disease was detected by I-131 scan. All were treated with ablation and remain disease-free (mean follow-up 42 months). Eight patients with local recurrence presented with palpable lesions; seven underwent surgery. While two patients developed repeated local recurrences, the other five remain disease-free (mean follow-up 52 months). Early detection and aggressive treatment of local recurrence improve survival in patients with well-differentiated thyroid carcinoma. To facilitate use of I-131, we advise total thyroidectomy for patients with well-differentiated thyroid carcinoma.

Adenocarcinoma↗

Craniotomy versus Endoscopic Membranectomy in the Treatment of Non-Homogeneous Chronic Subdural Hematoma: A Pilot Randomized Parallel-Group Active-Controlled Trial (EMiT CSDH 2).

BACKGROUND: Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition with persistent challenges related to recurrence. Endoscopic membranectomy (EM) has shown promising results in managing symptomatic non-homogenous (SNH)-CSDH, but comparative evidence against craniotomy with membranectomy (CM) is lacking. OBJECTIVES: To compare the safety and efficacy of EM versus CM in managing SNH-CSDH. MATERIALS AND METHODS: A pilot randomized parallel-group active-controlled open- labeled superiority trial from September 2023 to November 2024 at Government Kilpauk Medical College, Chennai, India. Sixty patients with SNH-CSDH were randomized into EM and CM groups. Recurrence was the primary outcome. Secondary outcomes included operative time, complications, radiological indices, pain, hospital stay, and functional recovery. All patients were followed for six months. RESULTS: No recurrence was observed in either group at six months. Two CM patients required reoperation on postoperative day one ( P = 0.15). EM was associated with shorter operative time ( P = 0.02), lower incidence of post-operative subdural residual fluid ( P = 0.015), better early hematoma reduction/subdural space reduction index ( P = 0.008), midline shift/symmetry improvement index ( P = 0.001), and lesser surgical site swelling ( P < 0.001). All patients were ambulant and had a Glasgow coma scale (GCS) 15 at discharge and at six months (including reoperated patients). Pain scores and functional recovery were comparable. EM patients had shorter hospital stays ( P = 0.004) and no significant complications. CONCLUSION: EM demonstrated favorable early radiological outcomes, fewer complications, and comparable functional recovery and recurrence versus CM in SNH-CSDH. Independent reproduction and larger multicentric trials are needed for validity and generalizability.

Humans↗