Anne-Marie van Berkel

Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones

BACKGROUND Endoscopic sphincterotomy (EST) for the removal of bileduct stones is associated with acute complications and a permanent loss of biliary-sphincter function. Endoscopic balloon dilation (EBD) causes less trauma to the biliary sphincter, but may be less effective in allowing stone removal. METHODS 218 consecutive patients with bileduct stones on endoscopic retrograde cholangiopancreatography (ERCP) were enrolled. 202 who met all eligibility criteria were randomly assigned EST or EBD. The patients were observed in hospital for at least 24 h and followed up at 1 month and 6 months. Complications were classified by an expert panel unaware of treatment allocation and outcome. Analysis was done by intention to treat. FINDINGS After a single ERCP, all stones were removed from 92 (91%) of 101 patients assigned EST and 90 (89%) of 101 assigned EBD (p = 0.81); in nine of the latter, successful removal required additional EST. Mechanical lithotripsy was used to fragment stones in 31 EBD procedures and 13 EST procedures (p < 0.005). Early complications (before 15 days) occurred in 24 EST patients and 17 EBD patients (p = 0.29). One patient died of retroperitoneal perforation after EBD. Four patients had bleeding after EST. Seven patients in each group had pancreatitis. Complications during follow-up occurred in 23 EST patients and 18 EBD patients (p = 0.48). Acute cholecystitis was observed in seven EST patients and one EBD patient (p < 0.05). INTERPRETATION The success rate of EBD was similar to that of EST. We found there is no evidence of the previously suggested higher risk of pancreatitis with EBD and suggest that EBD is preferred in patients at risk of bleeding after EST. Preservation of biliary-sphincter function after EBD may prevent long-term complications and reduce the risk of acute cholecystitis during follow-up. This procedure is a valuable alternative to EST in patients with bileduct stones.

Long-term results of endoscopic drainage of common bile duct strictures in chronic pancreatitis.

Objectives Endoscopic stent therapy is an established treatment modality for postoperative biliary strictures. At present, biliary stenting is also widely applied in chronic pancreatitis (CP), but results regarding long-term outcome are scarce. Methods All CP patients who underwent endoscopic biliary drainage of a benign stricture in our hospital between 1987 and 2000 were included in this retrospective study. Results Fifty-eight CP patients underwent biliary stenting (median age, 54 years; 44 male). The procedure-related mortality rate was 2% and the complication rate 4%. Median follow-up was 45 months (range, 0-182 months). Endoscopic treatment was successful in 22 patients (38%). Concomitant acute pancreatitis was the only factor identified as predictive of a successful outcome by multivariate analyses. Subanalysis of these 12 patients revealed a success rate of 92%, as opposed to 24% in cases without acute inflammation. In this latter group, continued stenting beyond a 1-year period almost never resulted in additional stricture resolvement. If stricture resolution was accomplished, however, no recurrences were observed. Conclusions For biliary strictures due to CP, without evidence of concomitant acute pancreatitis, the long-term success rate of endoscopic therapy is poor and only one out of four strictures is treated successfully. When a biliary stricture has not resolved after 1 year of endoscopic stenting, surgery should be considered.

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)

BackgroundAcute 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.Methods/designPatients 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN46462267.

A scanning electron microscopic study of biliary stent materials

BACKGROUND Clogging of biliary stents remains an important problem. In vitro studies have shown less sludge formation in Teflon stents. Recently, clinical studies with Teflon stents have produced contradictory results. The aim of this study was to investigate whether the surface properties of the endoprostheses could explain the variation observed in clinical studies. METHODS A total of 9 different types of unused 10F endoprostheses were examined by scanning electron microscopy (SEM): polyethylene Amsterdam-type, polyurethane Amsterdam-type, Teflon Amsterdam-type, Teflon Tannenbaum-type and a Tannenbaum-type stent with a thin stainless steel mesh between inner and outer layers. RESULTS All polyethylene stents had a relief with tiny lumps. All Teflon stents had multiple shallow pits and ridges along the entire longitudinal axis. Both Tannenbaum-type stents also had multiple particles protruding into the stent lumen with adjacent holes in the wall of the stent. The polyurethane stent had an extremely smooth surface. CONCLUSION SEM of Teflon made stents showed a markedly irregular inner surface, which may explain the controversial results of clinical studies. Our results indicate that the inner surface of a new stent should first be evaluated by SEM before clinical trials are initiated.

A prospective randomized trial of Tannenbaum-type Teflon-coated stents versus polyethylene stents for distal malignant biliary obstruction.

Objective Stent clogging is a major limitation in the palliative treatment of malignant biliary obstruction. Preliminary studies suggested improved duration of patency of a Tannenbaum design stent with a stainless steel mesh and an inner Teflon coating (TTC). We compared the patency of a TTC stent with a conventional polyethylene (PE) stent in a prospective randomized trial. Methods Between February 1998 and September 1998 we included 60 patients with distal malignant bile duct obstruction. Diagnosis included carcinoma of the pancreas (n = 57) and ampullary cancer (n = 3). There were 29 men and 31 women with a median age of 77 years. Stent diameter (10 Fr) and length (11 cm) were similar but both stent design and material were different: a Tannenbaum design stent with a stainless steel mesh and an inner Teflon coating, and an Amsterdam-type PE stent. Results Sixty patients were evaluated; 30 in the TTC group and 30 in the PE group. Early complications occurred in two patients in each group. Stent dysfunction occurred in 18 of TTC stents and 12 of PE stents. Median stent patency was 102 days for TTC and 142 days for PE stents (P = 0.41). Median survival did not differ significantly for both treatment groups (TTC, 121 days; PE, 105 days). Stent migration, in all cases proximal into the common bile duct, occurred in four patients in the TTC group versus zero in the PE group (P = 0.038). Conclusions This study did not confirm improved patency of Tannenbaum-type Teflon-coated stents. Proximal migration prompts for additional design modifications.

Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

BackgroundWith the availability of infliximab, nowadays recurrent Crohns disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohns disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohns disease of the distal ileum with respect to quality of life and costs.Methods/designThe study is designed as a multicenter randomized clinical trial including patients with Crohns disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007.DiscussionThe LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohns disease.Trial registrationNederlands Trial Register NTR1150

Long-Term Colon Stent Patency for Obstructing Colorectal Cancer Combined with Bevacizumab

Self-expanding metal stents can be considered as initial treatment for malignant large bowel obstruction in the palliative setting. It is suggested that systemic anti-angiogenic therapy increases the risk of stent perforation. We report a 65-year-old woman with a metastatic, obstructing colon tumor who has been successfully treated with stent placement and chemoimmunotherapy consisting of capecitabine and bevacizumab for 8 years.

4614 Is endoscopic balloon dilation for removal of bile duct stones associated with an increased rate of pancreatitis or hyperamylasemia

Background: EBD is an alternative to sphincterotomy (EST) for removal of bile duct stones in selected patients. EBD carries a reduced risk of bleeding and preserves sphincter function but may be associated with an increased risk of pancreatitis. Aim: to study the rate of hyperamylasemia and pancreatitis after EBD and EST and to investigate predictors for occurrence. Methods: 202 consecutive patients with bile duct stones of all sizes were randomized to EBD (8 mm balloon) or EST after deep cannulation of the bile duct#. Pancreatitis was defined as epigastric pain 24 hrs after the ERCP combined with at least a threefold rise in serum amylase level. Asymptomatic hyperamylasemia was defined as at least a threefold rise in the absence of epigastric pain. Results: 22 patients with prior BIIgastrectomy were excluded from the analysis. See table. Logistic regression of sex, age, stone characteristics, EBD vs. EST, additional EST after EBD, need for mechanical lithotripsy, pancreatography, and procedure time, identified EBD as the only significant predictor for asymptomatic hyperamylasemia. Conclusions: EBD is associated with an increased rate of asymptomatic hyperamylasemia. No difference in the rate of pancreatitis was observed. #Lancet 1997: 349:1124-9.

7250 Which factors predict the time required for stone removal after endoscopic balloon dilation (ebd) and sphincterotomy (est)

Aim: EBD is an alternative to EST in selected patients with bile duct stones. Since EBD does not enlarge the biliary orifice to the extent of EST, stone removal may be more difficult and more time consuming. We investigated which factors predict the time required for endoscopic stone removal after EBD and EST. Methods: 202 consecutive patients with bile duct stones of all sizes were randomized to EBD (8-mm dilation balloon)or EST after deep cannulation of the bile duct was achieved without preceeding precut * .In case stone removal failed after EBD an additional EST was performed. Mechanical lithotripsy was used when necessary. Stone removal time was defined as the time between randomization and end of the procedure. Results: 22 patients with a prior BII-gastrectomy were excluded from the analysis. See table for results. Multiple regression identified stone diameter, stone number, and EBD as independent predictors for stone removal time. Conclusions: Stone removal after EBD is more labour intensive than after EST and takes on average 10 minutes longer. The difference in stone removal time is most obvious for stone diameters between 10 and 15 mm where EBD requires mechanical lithotripsy in virtually all patients whereas this is not the case for EST.