Jeanin E. van Hooft

Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial

BACKGROUND Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction, but its benefits are uncertain. We aimed to establish whether colonic stenting has better health outcomes than does emergency surgery. METHODS Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherlands and randomly assigned (1:1 ratio) to receive colonic stenting as a bridge to elective surgery or emergency surgery. The randomisation sequence was computer generated with permuted blocks and was stratified by centre; treatment allocation was concealed by use of a web-based application. Investigators and patients were unmasked to treatment assignment. The primary outcome was mean global health status during a 6-month follow-up, which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30). Analysis was by intention to treat. This study is registered, number ISRCTN46462267. FINDINGS Between March 9, 2007, and Aug 27, 2009, 98 patients were assigned to receive colonic stenting (n=47 patients) or emergency surgery (n=51). Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group, with an absolute risk increase of 0.19 (95% CI -0.06 to 0.41) in analysis of the first 60 patients (14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery), and an absolute risk increase of 0.19 (-0.01 to 0.37) in analysis of the first 90 patients (23 of 47 patients vs 13 of 43). In accordance with the advice of the data safety monitoring committee, the study was suspended on Sept 18, 2009, and ended on March 12, 2010. At the final analysis of 98 patients, mean global health status during follow-up was 63.0 (SD 23.8) in the colonic stenting group and 61.4 (SD 21.9) in the emergency surgery group; after adjustment for baseline values, mean global health status did not differ between treatment groups (-4.7, 95% CI -14.8 to 5.5, p=0.36). No difference was recorded between treatment groups in 30-day mortality (absolute risk difference -0.01, 95% CI -0.14 to 0.12, p=0.89), overall mortality (-0.02, -0.17 to 0.14, p=0.84), morbidity (-0.08, -0.27 to 0.11, p=0.43), and stoma rates at latest follow-up (0.09, -0.10 to 0.27, p=0.35). However, the emergency surgery group had an increased stoma rate directly after initial intervention (0.23, 0.04 to 0.40, p=0.016) and a reduced frequency of stoma-related problems (between-group difference -12.0, -23.7 to -0.2, p=0.046). The most common serious adverse events were abscess (three in the colonic stenting group vs four in the emergency surgery group), perforations (six vs none), and anastomotic leakage (five vs one), and the most common adverse events were pneumonia (three vs one) and wound infection (one vs three). INTERPRETATION Colonic stenting has no decisive clinical advantages to emergency surgery. It could be used as an alternative treatment in as yet undefined subsets of patients, although with caution because of concerns about tumour spread caused by perforations. FUNDING None.

Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial

BACKGROUND Both gastrojejunostomy (GJJ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction (GOO). OBJECTIVE Compare GJJ and stent placement. DESIGN Multicenter, randomized trial. SETTING Twenty-one centers in The Netherlands. PATIENTS Patients with GOO. INTERVENTIONS GJJ and stent placement. MAIN OUTCOME MEASUREMENTS Outcomes were medical effects, quality of life, and costs. Analysis was by intent to treat. RESULTS Eighteen patients were randomized to GJJ and 21 to stent placement. Food intake improved more rapidly after stent placement than after GJJ (GOO Scoring System score > or = 2: median 5 vs 8 days, respectively; P < .01) but long-term relief was better after GJJ, with more patients living more days with a GOO Scoring System score of 2 or more than after stent placement (72 vs 50 days, respectively; P = .05). More major complications (stent: 6 in 4 patients vs GJJ: 0; P = .02), recurrent obstructive symptoms (stent: 8 in 5 patients vs GJJ: 1 in 1 patient; P = .02), and reinterventions (stent: 10 in 7 patients vs GJJ: 2 in 2 patients; P < .01) were observed after stent placement compared with GJJ. When stent obstruction was not regarded as a major complication, no differences in complications were found (P = .4). There were also no differences in median survival (stent: 56 days vs GJJ: 78 days) and quality of life. Mean total costs of GJJ were higher compared with stent placement (

A Combination of Molecular Markers and Clinical Features Improve the Classification of Pancreatic Cysts

16,535 vs

Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline

11,720, respectively; P = .049 [comparing medians]). Because of the small study population, only initial hospital costs would have been statistically significant if the Bonferroni correction for multiple testing had been applied. LIMITATIONS Relatively small patient population. CONCLUSIONS Despite slow initial symptom improvement, GJJ was associated with better long-term results and is therefore the treatment of choice in patients with a life expectancy of 2 months or longer. Because stent placement was associated with better short-term outcomes, this treatment is preferable for patients expected to live less than 2 months. ( CLINICAL TRIAL REGISTRATION NUMBER ISRCTN 06702358.).

A fully-covered stent (Alimaxx-E) for the palliation of malignant dysphagia: a prospective follow-up study

BACKGROUND & AIMS The management of pancreatic cysts poses challenges to both patients and their physicians. We investigated whether a combination of molecular markers and clinical information could improve the classification of pancreatic cysts and management of patients. METHODS We performed a multi-center, retrospective study of 130 patients with resected pancreatic cystic neoplasms (12 serous cystadenomas, 10 solid pseudopapillary neoplasms, 12 mucinous cystic neoplasms, and 96 intraductal papillary mucinous neoplasms). Cyst fluid was analyzed to identify subtle mutations in genes known to be mutated in pancreatic cysts (BRAF, CDKN2A, CTNNB1, GNAS, KRAS, NRAS, PIK3CA, RNF43, SMAD4, TP53, and VHL); to identify loss of heterozygozity at CDKN2A, RNF43, SMAD4, TP53, and VHL tumor suppressor loci; and to identify aneuploidy. The analyses were performed using specialized technologies for implementing and interpreting massively parallel sequencing data acquisition. An algorithm was used to select markers that could classify cyst type and grade. The accuracy of the molecular markers was compared with that of clinical markers and a combination of molecular and clinical markers. RESULTS We identified molecular markers and clinical features that classified cyst type with 90%-100% sensitivity and 92%-98% specificity. The molecular marker panel correctly identified 67 of the 74 patients who did not require surgery and could, therefore, reduce the number of unnecessary operations by 91%. CONCLUSIONS We identified a panel of molecular markers and clinical features that show promise for the accurate classification of cystic neoplasms of the pancreas and identification of cysts that require surgery.

Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). This Guideline was also reviewed and endorsed by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. ESGE guidelines represent a consensus of best practice based on the available evidence at the time of preparation. They may not apply in all situations and should be interpreted in the light of specific clinical situations and resource availability. Further controlled clinical studies may be needed to clarify aspects of these statements, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations. ESGE guidelines are intended to be an educational device to provide information that may assist endoscopists in providing care to patients. They are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment

A randomized comparison of electrocautery incision with Savary bougienage for relief of anastomotic gastroesophageal strictures

BACKGROUND The majority of the currently available metal stents are partially covered to reduce migration risk. However, one of the remaining issues is tissue ingrowth through the uncovered stent parts. OBJECTIVE To determine efficacy, recurrent dysphagia, and complications of a fully covered stent, ie, the Alimaxx-E stent, and to compare two stent delivery systems, ie, one introducing the stent over a guidewire and one introducing the stent over a small-caliber endoscope. DESIGN A prospective, follow-up study evaluating a new stent design, with randomization for type of introduction system. SETTING Three tertiary referral centers. PATIENTS Forty-five patients with inoperable or metastatic esophageal or gastric cardia cancer. INTERVENTIONS Stent placement. MAIN OUTCOME MEASUREMENTS (1) Functional outcome, recurrent dysphagia, complications, and mortality of the Alimaxx-E stent; (2) functional aspects of the delivery system. RESULTS At 4 weeks after stent placement, the dysphagia score improved in all patients (P < .001). Twenty-two of 45 patients (49%) developed among them 28 episodes of recurrent dysphagia, predominantly stent migration (n = 16). Major complications occurred in 9 of 45 patients (20%), with all 5 early (<1 week) complications (severe pain [n = 3], hemorrhage [n = 1], and fever [n = 1]) occurring in patients in whom the stent was introduced over the endoscope (P = .02). During follow-up, 44 patients died, 3 (7%) from hemorrhage. LIMITATION The Alimaxx-E stent was not randomly compared with other stent designs. CONCLUSIONS Placement of Alimaxx-E stents is safe and produces long-term relief of dysphagia, particularly when introduced over a guidewire. The migration rate of the Alimaxx-E stent is, however, unacceptably high, and an adapted stent design is needed.

Interfractional position variation of pancreatic tumors quantified using intratumoral fiducial markers and daily cone beam computed tomography

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It provides practical advice on how to achieve successful cannulation and sphincterotomy at minimum risk to the patient. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations 1 ESGE suggests that difficult biliary cannulation is defined by the presence of one or more of the following: more than 5 contacts with the papilla whilst attempting to cannulate; more than 5 minutes spent attempting to cannulate following visualization of the papilla; more than one unintended pancreatic duct cannulation or opacification (low quality evidence, weak recommendation). 2 ESGE recommends the guidewire-assisted technique for primary biliary cannulation, since it reduces the risk of post-ERCP pancreatitis (moderate quality evidence, strong recommendation). 3 ESGE recommends using pancreatic guidewire (PGW)-assisted biliary cannulation in patients where biliary cannulation is difficult and repeated unintentional access to the main pancreatic duct occurs (moderate quality evidence, strong recommendation). ESGE recommends attempting prophylactic pancreatic stenting in all patients with PGW-assisted attempts at biliary cannulation (moderate quality evidence, strong recommendation). 4 ESGE recommends needle-knife fistulotomy as the preferred technique for precutting (moderate quality evidence, strong recommendation). ESGE suggests that precutting should be used only by endoscopists who achieve selective biliary cannulation in more than 80 % of cases using standard cannulation techniques (low quality evidence, weak recommendation). When access to the pancreatic duct is easy to obtain, ESGE suggests placement of a pancreatic stent prior to precutting (moderate quality evidence, weak recommendation). 5 ESGE recommends that in patients with a small papilla that is difficult to cannulate, transpancreatic biliary sphincterotomy should be considered if unintentional insertion of a guidewire into the pancreatic duct occurs (moderate quality evidence, strong recommendation).In patients who have had transpancreatic sphincterotomy, ESGE suggests prophylactic pancreatic stenting (moderate quality evidence, strong recommendation). 6 ESGE recommends that mixed current is used for sphincterotomy rather than pure cut current alone, as there is a decreased risk of mild bleeding with the former (moderate quality evidence, strong recommendation). 7 ESGE suggests endoscopic papillary balloon dilation (EPBD) as an alternative to endoscopic sphincterotomy (EST) for extracting CBD stones < 8 mm in patients without anatomical or clinical contraindications, especially in the presence of coagulopathy or altered anatomy (moderate quality evidence, strong recommendation). 8 ESGE does not recommend routine biliary sphincterotomy for patients undergoing pancreatic sphincterotomy, and suggests that it is reserved for patients in whom there is evidence of coexisting bile duct obstruction or biliary sphincter of Oddi dysfunction (moderate quality evidence, weak recommendation). 9 In patients with periampullary diverticulum (PAD) and difficult cannulation, ESGE suggests that pancreatic duct stent placement followed by precut sphincterotomy or needle-knife fistulotomy are suitable options to achieve cannulation (low quality evidence, weak recommendation).ESGE suggests that EST is safe in patients with PAD. In cases where EST is technically difficult to complete as a result of a PAD, large stone removal can be facilitated by a small EST combined with EPBD or use of EPBD alone (low quality evidence, weak recommendation). 10 For cannulation of the minor papilla, ESGE suggests using wire-guided cannulation, with or without contrast, and sphincterotomy with a pull-type sphincterotome or a needle-knife over a plastic stent (low quality evidence, weak recommendation).When cannulation of the minor papilla is difficult, ESGE suggests secretin injection, which can be preceded by methylene blue spray in the duodenum (low quality evidence, weak recommendation). 11 In patients with choledocholithiasis who are scheduled for elective cholecystectomy, ESGE suggests intraoperative ERCP with laparoendoscopic rendezvous (moderate quality evidence, weak recommendation). ESGE suggests that when biliary cannulation is unsuccessful with a standard retrograde approach, anterograde guidewire insertion either by a percutaneous or endoscopic ultrasound (EUS)-guided approach can be used to achieve biliary access (low quality evidence, weak recommendation). 12 ESGE suggests that in patients with Billroth II gastrectomy ERCP should be performed in referral centers, with the side-viewing endoscope as a first option; forward-viewing endoscopes are the second choice in cases of failure (low quality evidence, weak recommendation). A straight standard ERCP catheter or an inverted sphincterotome, with or without the guidewire, is recommended by ESGE for biliopancreatic cannulation in patients who have undergone Billroth II gastrectomy (low quality evidence, strong recommendation). Endoscopic papillary ballon dilation (EPBD) is suggested as an alternative to sphincterotomy for stone extraction in the setting of patients with Billroth II gastrectomy (low quality evidence, weak recommendation).In patients with complex post-surgical anatomy ESGE suggests referral to a center where device-assisted enteroscopy techniques are available (very low quality evidence, weak recommendation).

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)

BACKGROUND Benign gastroesophageal anastomotic strictures are common and often refractory to treatment. Various endoscopic dilation techniques have been reported, but none of these methods has been proven to be superior. OBJECTIVE Comparison of the efficacy and safety of dilation of previously untreated anastomotic strictures by using electrocautery incision (EI) and Savary bougienage (SB). DESIGN Randomized, prospective study. SETTING Multicenter study. PATIENTS Sixty-two patients with an anastomotic stricture after esophagogastrostomy and dysphagia Atkinson grades II to IV were included. INTERVENTIONS Patients were treated with EI or SB. MAIN OUTCOME MEASUREMENTS Objective and subjective results were compared with baseline and 1, 3, and 6 months after the first treatment. Complications of both treatments were noted. Primary endpoints after 6 months were the mean number of dilation sessions and success rate (percentage of patients with < or =5 dilations in 6 months). Study participation ended after 6 months or if dysphagia grades II to IV recurred despite 5 treatment sessions. RESULTS No complications occurred with both treatments. There was no significant difference between the EI and SB groups in the mean number of dilations (2.9; 95% CI, 2.7-4.1 vs 3.3; 95% CI, 2.3-3.6l; P = .46) or the success rate (80.6% vs 67.7%, P = .26 and 96.2% vs 80.8%, P = .19). LIMITATIONS In a small study with negative primary endpoints, secondary endpoints and subgroup analyses are hypothesis generating only. CONCLUSIONS This prospective trial demonstrated that EI of gastroesophageal anastomotic strictures is a safe therapy and equivalent to SB as a primary therapy. EI can be used as an alternative or additional therapy to SB. (Registered with Current Controlled Trials, Ltd, registration number ISRCTN81239664.).

Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study.

PURPOSE The aim of this study was to quantify interfractional pancreatic position variation using fiducial markers visible on daily cone beam computed tomography (CBCT) scans. In addition, we analyzed possible migration of the markers to investigate their suitability for tumor localization. METHODS AND MATERIALS For 13 pancreatic cancer patients with implanted Visicoil markers, CBCT scans were obtained before 17 to 25 fractions (300 CBCTs in total). Image registration with the reference CT was used to determine the displacement of the 2 to 3 markers relative to bony anatomy and to each other. We analyzed the distance between marker pairs as a function of time to identify marker registration error (SD of linear fit residuals) and possible marker migration. For each patient, we determined the mean displacement of markers relative to the reference CT (systematic position error) and the spread in displacements (random position error). From this, we calculated the group systematic error, Σ, and group random error, σ. RESULTS Marker pair distances showed slight trends with time (range, -0.14 to 0.14 mm/day), possibly due to tissue deformation, but no shifts that would indicate marker migration. The mean SD of the fit residuals was 0.8 mm. We found large interfractional position variations, with for 116 of 300 (39%) fractions a 3-dimensional vector displacement of >10 mm. The spread in displacement varied significantly (P<.01) between patients, from a vector range of 9.1 mm to one of 24.6 mm. For the patient group, Σ was 3.8, 6.6, and 3.5 mm; and σ was 3.6, 4.7 and 2.5 mm, in left-right, superior-inferior, and anterior-posterior directions, respectively. CONCLUSIONS We found large systematic displacements of the fiducial markers relative to bony anatomy, in addition to wide distributions of displacement. These results for interfractional position variation confirm the potential benefit of using fiducial markers rather than bony anatomy for daily online position verification for pancreatic cancer patients.