A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy

Purpose

Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT (ClinicalTrials.gov NCT01240772) according to the type of devices used.

Methods

In the DGHAL arm (N?=?193), the procedure was done with transanal hemorrhoidal dearterialization (THD)? (THD, Correggio, Italy) (104 patients) and with HAL-RAR? (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N?=?184), procedure for prolapse and hemorrhoids (PPH)-03? (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)? (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected.

Results

Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p?<?0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p?=?0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation.

Conclusion

Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results.

Trial registration

clinicaltrials.gov—Identifier NCT01240772

     

Clinical characteristics and prognostic factors of sinonasal undifferentiated carcinoma: a multicenter study

Background

Sinonasal undifferentiated carcinoma (SNUC) is a very rare entity with a poor prognosis. Due to the lack of studies on the subject, evidence is lacking concerning its management.

Methods

A multicenter collaborative study was conducted to assess treatment strategy, oncological outcome, and prognostic factors.

Results

Definitive analyses focused on 54 patients with a majority of advanced stage; the 3‐year overall survival (OS) and 3‐year recurrence‐free survival (RFS) rates were, respectively, 62.4% and 47.8%. During the follow‐up, 18 patients (33.3%) died, 10 (18.5%) developed metastases, 7 had lymph‐node involvement (13%), and 12 (22.2%) showed recurrence or local progression. In univariate analyses, treatment modalities associated with improved RFS were induction chemotherapy (p = 0.02) and intensity‐modulated radiotherapy (p = 0.007). In the multivariate analyses, only induction chemotherapy (p = 0.047, hazard ratio [HR] = 0.39) was significantly associated with improved RFS.

Conclusion

Multimodal therapies including induction chemotherapy and intensity‐modulated radiotherapy may improve the prognosis of SNUC; surgery might improve local control. Further multicenter studies are required.

     

Gene transfer by guanidinium-cholesterol cationic lipids into airway epithelial cells in vitro and in vivo

Synthetic vectors represent an attractive alternative approach to viral vectors for gene transfer, in particular into airway epithelial cells for lung-directed gene therapy for cystic fibrosis. Having recently found that guanidinium-cholesterol cationic lipids are efficient reagents for gene transfer into mammalian cell lines in vitro, we have investigated their use for gene delivery into primary airway epithelial cells in vitro and in vivo. The results obtained indicate that the lipid bis(guanidinium)-tren-cholesterol (BGTC) can be used to transfer a reporter gene into primary human airway epithelial cells in culture. Furthermore, liposomes composed of BGTC and dioleoyl phosphatidylethanolamine (DOPE) are efficient for gene delivery to the mouse airway epithelium in vivo. Transfected cells were detected both in the surface epithelium and in submucosal glands. In addition, the transfection efficiency of BGTC/DOPE liposomes in vivo was quantitatively assessed by using the luciferase reporter gene system.     

Full-blown graft-versus-host disease presenting with skin manifestations,jaundice and diarrhoea: an unusual paraneoplastic phenomenon of a thymoma

We describe a patient who presented with chronic diarrhoea, skin lesions and jaundice. Based on histopathological examinations of the affected organs combined with the clinical features, it appeared that the patient fulfilled the criteria for graft-versus-host disease (GVHD). GVHD occurs especially after allogeneic stem cell transplantation and sometimes after organ transplantations. However, this patient had never undergone such a procedure. Further examination revealed that the patient also suffered from a thymoma, which was concluded to be the cause of GVHD. Unfortunately, the patient died after resection of the thymoma. This patient is probably the second case with thymoma and full-blown GVHD and shows that GVHD can occur in the absence of a previous transplantation.     

Practical screening and early treatment of hepatocellular carcinoma. Results of a French survey

AIM: To describe French practices for screening hepatocellular carcinoma. METHODS: A standardized questionnaire was mailed to all French hospital hepato-gastroenterologists in June 1999. RESULTS: 411 out of 623 practitioners responded (66%). 394 (96%) routinely screen hepatocellular carcinoma, mainly with ultrasound (98%) and mainly at 6-month intervals (77%). Screening was performed in cirrhosis (100%) or extensive fibrosis (54%), independent of the etiology (21%) or the Child-Pugh score of the chronic liver disease (41%), but based on age and treatment feasibility. If of a small hypoechogenic nodule was detected in a young patient with compensated HCV-cirrhosis, 59% of practitioners performed a histological examination. In case of non biopsy-proven hepatocellular carcinoma, a second biopsy (49%), treatment (either percutaneous alcohol injection, resection or transplantation) (24%) or an ultrasonographic follow-up (23%) was proposed. In case of biopsy-proven hepatocellular carcinoma, resection (49%), transplantation (30%) or percutaneous alcohol injection (16%) was proposed. CONCLUSION: Almost all French specialists routinely screen cirrhotic patients for hepatocellular carcinoma, but use somewhat different modalities. In case of small HCC without contraindications to curative treatment, surgical resection is performed in half the patients.     

Carcinomas of the colon with multidirectional differentiation

Summary Two cases of colonic carcinomas with multidirectional differentiation are presented. Both tumors showed light microscopic and immunohistochemical evidence of areas of adenocarcinomatous, squamous cell carcinomatous, and neuroendocrine differentiation. Only six similar cases have been previously reported. These highly malignant tumors support the recent concept of a multipotential stem cell within the mucosa of the gastrointestinal tract capable of differentiation in several directions.     

A mouse model for the renal salt-wasting syndrome pseudohypoaldosteronism

Aldosterone-dependent epithelial sodium transport in the distal nephron is mediated by the absorption of sodium through the highly selective, amiloride-sensitive epithelial sodium channel (ENaC) made of three homologous subunits (α, β, and γ). In human, autosomal recessive mutations of α, β, or γENaC subunits cause pseudohypoaldosteronism type 1 (PHA-1), a renal salt-wasting syndrome characterized by severe hypovolemia, high plasma aldosterone, hyponatremia, life-threatening hyperkaliemia, and metabolic acidosis. In the mouse, inactivation of αENaC results in failure to clear fetal lung liquid at birth and in early neonatal death, preventing the observation of a PHA-1 renal phenotype. Transgenic expression of αENaC driven by a cytomegalovirus promoter in αENaC(−/−) knockout mice [αENaC(−/−)Tg] rescued the perinatal lethal pulmonary phenotype and partially restored Na⁺ transport in renal, colonic, and pulmonary epithelia. At days 5–9, however, αENaC(−/−)Tg mice showed clinical features of severe PHA-1 with metabolic acidosis, urinary salt-wasting, growth retardation, and 50% mortality. Adult αENaC(−/−)Tg survivors exhibited a compensated PHA-1 with normal acid/base and electrolyte values but 6-fold elevation of plasma aldosterone compared with wild-type littermate controls. We conclude that partial restoration of ENaC-mediated Na⁺ absorption in this transgenic mouse results in a mouse model for PHA-1.     

Percutaneous mitral valvuloplasty in the adult. Apropos of 5 cases

The results of percutaneous mitral valvuloplasty in 5 adult patients with mitral stenosis are presented. The average age was 55 years (37-72 years); 4 patients were in functional Class III and 1 in Class IV. The three oldest patients were in atrial fibrillation, and 2 of them had severe valvular and subvalvular lesions. Valvuloplasty was carried out with a "Trefoil" balloon (3 X 12 mm; effective cross sectional area at maximal inflation: 3.8 cm2). The procedure was successful in 4 patients. In the other patient, it was not possible to position the balloon across the stenotic valve. After valvuloplasty, the mean mitral gradient decreased (14 +/- 5 to 6 +/- 2 mmHg, p less than 0.05) without a significant change in cardiac index (2.9 +/- 0.5 vs 2.7 +/- 0.4 l/mn/m2; NS): this indicated an increased mitral valve surface area (1.1 +/- 0.2 to 1.8 +/- 0.05 cm2, p less than 0.05). In parallel, echocardiographic measurements of mitral valve surface area increased from 0.9 +/- 0.2 to 1.8 +/- 0.3 cm2, p less than 0.05, and Doppler pressure halt time fell from 220 +/- 50 to 116 +/- 13 ms, p less than 0.05. There were no operative complications and, in particular, no resulting angiographic mitral regurgitation. These preliminary results suggest that percutaneous mitral valvuloplasty may be a valuable alternative therapeutic procedure to surgery in selected patients.