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1.  Clinical outcomes of self-expandable stent placement for benign esophageal diseases: A pooled analysis of the literature 
AIM: To analyze the outcomes of self-expandable stent placement for benign esophageal strictures and benign esophageal leaks in the literature.
METHODS: The PubMed, Embase and Cochrane databases were searched for relevant articles published between January 2000 and July 2014. Eight prospective studies were identified that analyzed the outcomes of stent placement for refractory benign esophageal strictures. The outcomes of stent placement for benign esophageal leaks, perforations and fistulae were extracted from 20 retrospective studies that were published after the inclusion period of a recent systematic review. Data were pooled and analyzed using descriptive statistics.
RESULTS: Fully covered self-expandable metal stents (FC SEMS) (n = 85), biodegradable (BD) stents (n = 77) and self-expandable plastic stents (SEPS) (n = 70) were inserted in 232 patients with refractory benign esophageal strictures. The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS. Stent migration occurred in 24.6% of cases. The overall complication rate was 31.0%, including major (17.7%) and minor (13.4%) complications. A total of 643 patients were treated with self-expandable stents mainly for postsurgical leaks (64.5%), iatrogenic perforations (19.6%), Boerhaave’s syndrome (7.8%) and fistulae (3.7%). FC SEMS and partially covered SEMS were used in the majority of patients. Successful closure of the defect was achieved in 76.8% of patients and according to etiology in 81.4% for postsurgical leaks, 86.0% for perforations and 64.7% for fistulae. The pooled stent migration rate was 16.5%. Stent-related complications occurred in 13.4% of patients, including major (7.8%) and minor (5.5%) complications.
CONCLUSION: The outcomes of stent placement for refractory benign esophageal strictures were poor. However, randomized trials are needed to put this into perspective. The evidence on successful stent placement for benign esophageal leaks, perforations and fistulae is promising.
PMCID: PMC4325310  PMID: 25685270
Self-expandable stents; Benign esophageal strictures; Esophageal perforation; Esophageal fistula; Anastomotic leak; Systematic review
2.  Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial 
BMC Gastroenterology  2013;13:49.
In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis.
The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥ 5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥ 4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%).
The ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice.
Trial registration
PMCID: PMC3610165  PMID: 23506415
Chronic pancreatitis; Pain; Surgical management; Surgery; Endoscopic treatment; Endoscopy; ERCP; Opioid; Pancreaticojejunostomy; Frey procedure
3.  Endoscopic ultrasonography-guided fine needle aspiration: Relatively low sensitivity in the endosonographer population 
AIM: To assess the characteristics and quality of endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) in a large panel of endosonographers.
METHODS: A survey was conducted during the 13th annual live course of endoscopic ultrasonography (EUS) held in Amsterdam, Netherlands. A 2-page questionnaire was developed for the study. Content validity of the questionnaire was determined based on input by experts in the field and a review of the relevant literature. It contained 30 questions that pertained to demographics and the current practice for EUS-FNA of responders, including sampling technique, sample processing, cytopathological diagnosis and sensitivity of EUS-FNA for the diagnosis of solid mass lesions. One hundred and sixty-one endosonographers who attended the course were asked to answer the survey. This allowed assessing the current practice of EUS-FNA as well as the self-reported sensitivity of EUS-FNA for the diagnosis of solid mass lesions. We also examined which factors were associated with a self-reported sensitivity of EUS-FNA for the diagnosis of solid mass lesions > 80%.
RESULTS: Completed surveys were collected from 92 (57.1%) of 161 endosonographers who attended the conference. The endosonographers had been practicing endoscopy and EUS for 12.5 ± 7.8 years and 4.8 ± 4.1 years, respectively; one third of them worked in a hospital with an annual caseload > 100 EUS-FNA. Endoscopy practices were located in 29 countries, including 13 countries in Western Europe that totaled 75.3% of the responses. Only one third of endosonographers reported a sensitivity for the diagnosis of solid mass lesions > 80% (interquartile range of sensitivities, 25.0%-75.0%). Factors independently associated with a sensitivity > 80% were (1) > 7 needle passes for pancreatic lesions or rapid on-site cytopathological evaluation (ROSE) (P < 0.0001), (2) a high annual hospital caseload (P = 0.024) and (3) routine isolation of microcores from EUS-FNA samples (P = 0.042). ROSE was routinely available to 27.9% of respondents. For lymph nodes and pancreatic masses, a maximum of three needle passes was performed by approximately two thirds of those who did not have ROSE. Microcores were routinely harvested from EUS-FNA samples by approximately one third (37.2%) of survey respondents.
CONCLUSION: EUS-FNA sensitivity was considerably lower than reported in the literature. Low EUS-FNA sensitivity was associated with unavailability of ROSE, few needle passes, absence of microcore isolation and low hospital caseload.
PMCID: PMC3353369  PMID: 22654426
Caseload; Community surveys; Cytopathology; Endoscopic ultrasonography; Histopathology; Quality improvement
4.  Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study) 
BMC Surgery  2007;7:12.
Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion.
Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics.
The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction.
Trial registration
Current Controlled Trials ISRCTN46462267.
PMCID: PMC1925059  PMID: 17608947

Results 1-4 (4)