In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal ...Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.
Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.
This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.
Netherlands Trial Register, NL7083 , 06 July 2018.
Abstract Background: Refractory celiac disease (RCD) patients with aberrant, often clonal, intraepithelial T-cells are at high risk for development of enteropathy associated T-cell lymphoma (EATL). ...Early detection of those patients that actually develop EATL is of utmost importance for curative intervention. Aim: First, to establish an optimal cut-off value for the percentage of aberrant lymphocytes, previously determined based on clinical observations, via reference ranges for aberrant T-cells in the duodenal mucosa of celiac disease patient and control groups. Secondly, to compare aberrancy with intestinal T-cell clonality as a prognostic parameter for EATL development in RCD. Methods: Immunophenotyping using flow cytometry was performed on small intestinal biopsy-derived lymphocytes, obtained from distinct celiac disease (CD) patient and control groups ( N = 167 in total). T-cell clonality in duodenal biopsy specimens was assessed by PCR in RCD, ulcerative jejunitis and EATL patients ( N = 31 in total). Results: In 95% of non-refractory CD patients, the highest percentage aberrant T-cells was 20%. Using this cut-off value, EATL development was exclusively seen in RCD with more than 20% aberrant T-cells (median 52% aberrant T-cells, range 27–94%). When compared with T-cell clonality analysis, > 20% aberrancy showed a much higher negative predictive value and sensitivity (both 100%) for EATL development in RCD patients than T-cell clonality analysis (respectively 75% and 78%). Conclusions: Quantification of aberrant T-cells by flow cytometry is preferable to T-cell clonality analysis for identification of RCD patients at risk for EATL development. A cut-off value of 20% is of use in risk stratification, therapeutic options and subsequent follow-up of RCD patients.
Background In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is ...Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. Methods Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. Discussion This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. Trial registration Netherlands Trial Register, NL7083, 06 July 2018. Keywords: Endoscopic submucosal dissection, Transanal minimally invasive surgery, Rectal cancer, Adenoma
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural ...hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP.
The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness.
The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs.
EudraCT: 2015-000829-37 . Registered on 18 February 2015.
13659155 . Registered on 18 May 2015.
Refractory celiac disease (RCD) can evolve into enteropathy-associated T-cell lymphoma (EATL). ^sup 18^F-FDG PET has been reported to discriminate between RCD and EATL. Because prospective data are ...lacking, we designed a prospective study to evaluate the potential of ^sup 18^F-FDG PET for detection of EATL in patients with RCD and compared the results with those obtained using abdominal CT in a referral center. Between April 2003 and April 2005, 8 consecutive patients (median age, 66 y; range, 52 - 89 y) with EATL and 30 patients (median age, 61 y; range, 44 - 71 y) with RCD were included. CT and ^sup 18^F-FDG PET were performed on all patients. Histologic evidence of EATL was identified in tissue samples obtained during upper gastrointestinal endoscopy or surgical resection. Villous atrophy was found in all patients with RCD and all (except 1) patients with EATL in nontumoral mucosa. Histologic examination of 1 patient with EATL localized in the duodenum showed intraepithelial lymphocytosis only. ^sup 18^F-FDG PET could reveal sites histologically proven to be EATL in all 8 patients, whereas CT showed normal findings in 1 patient with EATL. ^sup 18^F-FDG PET detected unsuspected extraintestinal sites affected by EATL in 2 patients. CT showed abnormalities such as a thickened small-bowel wall or lymphadenopathy in 14 patients with RCD lacking evidence of EATL at follow-up. ^sup 18^F-FDG PET findings were positive in 3 and equivocal in another 3 patients with RCD. ^sup 18^F-FDG PET was more sensitive and specific than CT (100% vs. 87% and 90% vs. 53%, respectively). Our data show that ^sup 18^F-FDG PET is more sensitive in detecting EATL in patients with RCD than is CT. ^sup 18^F-FDG PET, in addition to conventional CT, is recommended for evaluating patients with RCD.
Refractory celiac disease (RCD) can evolve into enteropathy-associated T-cell lymphoma (EATL). 18F-FDG PET has been reported to discriminate between RCD and EATL. Because prospective data are ...lacking, we designed a prospective study to evaluate the potential of 18F-FDG PET for detection of EATL in patients with RCD and compared the results with those obtained using abdominal CT in a referral center.
Between April 2003 and April 2005, 8 consecutive patients (median age, 66 y; range, 52-89 y) with EATL and 30 patients (median age, 61 y; range, 44-71 y) with RCD were included. CT and 18F-FDG PET were performed on all patients. Histologic evidence of EATL was identified in tissue samples obtained during upper gastrointestinal endoscopy or surgical resection.
Villous atrophy was found in all patients with RCD and all (except 1) patients with EATL in nontumoral mucosa. Histologic examination of 1 patient with EATL localized in the duodenum showed intraepithelial lymphocytosis only. 18F-FDG PET could reveal sites histologically proven to be EATL in all 8 patients, whereas CT showed normal findings in 1 patient with EATL. 18F-FDG PET detected unsuspected extraintestinal sites affected by EATL in 2 patients. CT showed abnormalities such as a thickened small-bowel wall or lymphadenopathy in 14 patients with RCD lacking evidence of EATL at follow-up. 18F-FDG PET findings were positive in 3 and equivocal in another 3 patients with RCD. 18F-FDG PET was more sensitive and specific than CT (100% vs. 87% and 90% vs. 53%, respectively).
Our data show that 18F-FDG PET is more sensitive in detecting EATL in patients with RCD than is CT. 18F-FDG PET, in addition to conventional CT, is recommended for evaluating patients with RCD.
Coeliac disease in Dutch patients with Hashimoto＇s thyroiditis and vice versa Muhammed Hadithi Hans de Boer Jos WR Meijer Frans Willekens Jo A Kerckhaert Roel Heijmans Amado Salvador Pena Coen DA Stehouwer Chris JJ Mulder
World journal of gastroenterology : WJG,
2007, Letnik:
13, Številka:
11
Journal Article
AIM： To define the association between Hashimoto＇s thyroiditis and coeliac disease in Dutch patients. METHODS： A total of 104 consecutive patients with Hashimoto＇s thyroiditis underwent coeliac ...serological tests （antigliadins, transglutaminase and endomysium antibodies） and HLA-DQ typing. Small intestinal biopsy was performed when any of coeliac serological tests was positive. On the other hand, 184 patients with coeliac disease were subjected to thyroid biochemical （thyroid stimulating hormone and free thyroxine） and thyroid serological tests （thyroglobulin and thyroid peroxidase antibodies）. RESULTS： Of 104 patients with Hashimoto＇s thyroiditis, sixteen （15%） were positive for coeliac serology and five patients with documented villous atrophy were diagnosed with coeliac disease （4.8%; 95% CI 0.7-8.9）. HLA-DQ2 （and/or -DQ8） was present in all the five and 53 patients with Hashimoto＇s thyroiditis （50%; 95% CI 43-62）. Of 184 patients with coeliac disease, 39 （21%） were positive for thyroid serology. Based on thyroid biochemistry, the 39 patients were subclassified into euthyroidism in ten （5%; 95% CI 2-9）, subclinical hypothyroidism in seven （3.8%; 95% CI 1.8-7.6）, and overt hypothyroidism （Hashimoto＇s thyroiditis） in 22 （12%; 95% CI 8-16）. Moreover, four patients with coeliac disease had Graves＇ disease （2%; 95% CI 0.8-5） and one patient had post-partum thyroiditis. CONCLUSION： The data from a Dutch population confirm the association between Hashimoto＇s thyroiditis and coeliac disease. Screening patients with Hashimoto＇s thyroiditis for coeliac disease and vice versa is recommended.
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