Split-dose bowel cleansing with picosulphate is safe and better tolerated than 2-l polyethylene glycol solution.

BACKGROUND: In physically less fit patients and patients requiring repeated exams, adequate bowel preparation for colonoscopy remains problematic, particularly because patients need to drink large volumes of unpleasant-tasting fluids. A further concern is potential unwarranted fluid shifts. AIMS: This study aimed to compare the safety and burden of a small-volume sodium picosulphate/magnesium citrate preparation (SPS-MC) with a 2-l ascorbic-acid-enriched polyethylene glycol solution plus bisacodyl pretreatment (PEG-Asc+B). PATIENTS AND METHODS: Patients referred for colonoscopy were randomized to SPS-MC or PEG-Asc+B administered as a split-dose regimen. Patients received advice on the recommended 4-l SPS-MC and 2-l PEG-Asc+B fluid intake. Safety was assessed by blood sampling before and after the preparation and during a 30-day follow-up period. A questionnaire assessed tolerability and perceived burden of the preparation. RESULTS: A total of 341 patients underwent colonoscopy. Blood sampling showed a slight but significant decrease in sodium, chloride and osmolality and increase in magnesium in the SPS-MC group and a decrease in bicarbonate in the PEG-Asc+B group. Hyponatraemia and hypermagnesaemia without clinical signs were observed in 16 (14 SPS-MC) and 13 SPS-MC patients, respectively. Patients reported significantly fewer physical complaints and a significantly higher completion rate with SPS-MC. Patients receiving SPS-MC rated the intake as being easier and better tasting. In the event of a repeat colonoscopy, 59.7% of patients in the PEG-Asc+B and 93.6% of patients in the SPS-MC group would opt for the same preparation again. CONCLUSION: Despite electrolyte shifts, both SPS-MC and PEG-Asc+B appeared clinically safe. From a patient's perspective, a small-volume preparation formula such as SPS-MC is preferred, resulting in fewer physical complaints and greater ease of intake.

Efficacy and Safety of Sodium Picosulfate/Magnesium Citrate for Bowel Preparation in a Physically Disabled Outpatient Population: A Randomized, Endoscopist-Blinded Comparison With Ascorbic Acid-Enriched Polyethylene Glycol Solution Plus Bisacodyl (The PICO-MOVI Study).

BACKGROUND: Because of its volume, adequate bowel preparation remains problematic in physically unfit patients. OBJECTIVE: This study aimed to compare a small-volume sodium picosulfate/magnesium citrate preparation with a 2-L ascorbic acid-enriched polyethylene glycol solution plus bisacodyl. DESIGN: This study has a noninferiority design, assuming that ascorbic acid-enriched polyethylene glycol solution plus bisacodyl is 70% efficacious in achieving an Ottawa score ≤7 and accepting a difference in success rate of <15% with a target enrollment of 146 patients per group. SETTING: This study was conducted in an outpatient department. PATIENTS: Patients referred for diagnostic colonoscopy were randomly assigned. Key exclusion criteria were severe kidney disease, ASA class ≥III, and hospital admission. INTERVENTION: Patients were randomly assigned to receive sodium picosulfate/magnesium citrate or ascorbic acid-enriched polyethylene glycol solution plus bisacodyl according to a split-dose regimen. Patients in the sodium picosulfate/magnesium citrate group received advice on the recommended 4-L fluid intake. Patients in the ascorbic acid-enriched polyethylene glycol solution plus bisacodyl group received 2 bisacodyl tablets 2 days before and advice on the additionally recommended 2-L fluid intake. MAIN OUTCOME MEASURES: To assess bowel-cleansing adequacy, the Ottawa, Aronchick, and Boston scores were used. Colonoscopy quality measures were obtained. Safety was assessed for a 30-day follow-up period. RESULTS: Overall, 341 patients (169 men, mean age 57.0 years; BMI 26.2 kg/m) were included. Comorbidities were present in 76.2% of patients, and 75.4% of patients used medication. An adequate Ottawa score was obtained in 81.4% and 75.8% of patients receiving ascorbic acid-enriched polyethylene glycol solution plus bisacodyl and sodium picosulfate/magnesium citrate (difference of 5.6% (95% CI, -3.5 to -14.6; p = 0.023)), showing noninferiority of the sodium picosulfate/magnesium citrate therapy. Ottawa segmental scores were lower for sodium picosulfate/magnesium citrate in the right and transverse colon. In both groups, successful ileocecal intubation was achieved in 95%. No medication-related adverse events were reported. LIMITATIONS: These results in a physically disabled ambulant population cannot be extrapolated to immobile, hospitalized patients. CONCLUSIONS: Sodium picosulfate/magnesium citrate proved to be noninferior to ascorbic acid-enriched polyethylene glycol solution plus bisacodyl in efficacy and safety. Timing of the colonoscopy and addition of bisacodyl to sodium picosulfate/magnesium citrate warrants further consideration. See Video Abstract at http://links.lww.com/DCR/A461.

Is Endoscopy Really Necessary for Placing Intragastric Balloons?

BACKGROUND: Gastric balloons for weight loss have historically been placed after a screening endoscopy. However, the utility and yield of these endoscopies has not been studied. Therefore, we wanted to evaluate the utility of screening endoscopy and to assess patients who had balloons placed without endoscopy. METHODS: Data was collected on two cohorts. Cohort 1 consisted of patients who had a screening endoscopy prior to or upon balloon placement. Cohort 2 consisted of patients who were followed after having a balloon placed under fluoroscopic guidance without endoscopy. Balloon intolerance and findings on removal endoscopy were assessed in both cohorts. RESULTS: In cohort 1 (n = 253), two patients had severe symptoms on history; balloon placement was contraindicated based on screening endoscopy findings. Eleven patients with a history of hiatal hernia and the presence of severe belching demonstrated an insignificant hiatal hernia on endoscopy. In cohort 2 (n = 50), all patients had an unremarkable history. Three previously asymptomatic patients had balloon intolerance and one was found to have a 4-cm hiatal hernia and oesophagitis upon balloon removal. Out of 194 patients, 25 were either intolerant to the balloon or had relevant findings on removal endoscopy. Findings on screening endoscopy did not correlate with balloon intolerance or findings on removal endoscopy. CONCLUSION: These results demonstrate that a careful history can identify patients who may have contraindications for balloon therapy and that balloons can be placed safely after taking a careful history without screening endoscopy. Screening endoscopy may not be useful in predicting balloon intolerance or potential complications.

Incidence of small bowel neoplasia in Lynch syndrome assessed by video capsule endoscopy.

BACKGROUND AND STUDY AIMS: Lynch syndrome (LS) patients have an increased risk of small bowel cancer. The question is whether surveillance will lead to early detection of (pre)malignant lesions. We recently reported on prevalence of small bowel neoplasia (SBN) in LS patients as assessed by video capsule endoscopy (VCE). The aim of this prospective study was to determine the incidence of SBN. PATIENTS AND METHODS: Asymptomatic LS patients who underwent a VCE were invited to undergo a second VCE procedure 2 years later. If abnormalities or polypoid lesions larger than 1 cm were detected, subsequent endoscopic procedures were performed. RESULTS: A total of 155 (78 %) of the initial 200 patients underwent a second VCE procedure after a mean of 2.2 (range 1 - 6) years. In 17 of the 155 (11 %) patients possibly significant lesions were detected, which required further investigation by means of gastroduodenoscopy (n = 8) or balloon-assisted endoscopy (n = 9). These procedures revealed no SBN. CONCLUSION: No SBN was found after 2 years. Surveillance of the small bowel by VCE does not seem to be warranted in asymptomatic LS patients.

Electromagnetic-Guided Bedside Placement of Nasoenteral Feeding Tubes by Nurses Is Non-Inferior to Endoscopic Placement by Gastroenterologists: A Multicenter Randomized Controlled Trial.

OBJECTIVES: Electromagnetic (EM)-guided bedside placement of nasoenteral feeding tubes by nurses may improve efficiency and reduce patient discomfort and costs compared with endoscopic placement by gastroenterologists. However, evidence supporting this task shift from gastroenterologists to nurses is limited. We aimed to compare the effectiveness of EM-guided and endoscopic nasoenteral feeding tube placement. METHODS: We performed a multicenter randomized controlled non-inferiority trial in 154 adult patients who required nasoenteral feeding and were admitted to gastrointestinal surgical wards in five Dutch hospitals. Patients were randomly assigned (1:1) to undergo EM-guided or endoscopic nasoenteral feeding tube placement. The primary end point was the need for reinsertion of the feeding tube (e.g., after failed initial placement or owing to tube-related complications) with a prespecified non-inferiority margin of 10%. RESULTS: Reinsertion was required in 29 (36%) of the 80 patients in the EM-guided group and 31 (42%) of the 74 patients in the endoscopy group (absolute risk difference -6%, upper limit of one-sided 95% confidence interval 7%; P for non-inferiority=0.022). No differences were noted in success and complication rates. In the EM-guided group, there was a reduced time to start of feeding (424 vs. 535 min, P=0.001). Although the level of discomfort was higher in the EM-guided group (Visual Analog Scale (VAS) 3.9 vs. 2.0, P=0.009), EM-guided placement received higher recommendation scores (VAS 8.2 vs. 5.5, P=0.008). CONCLUSIONS: EM-guided bedside placement of nasoenteral feeding tubes by nurses was non-inferior to endoscopic placement by gastroenterologists in surgical patients and may be considered the preferred technique for nasoenteral feeding tube placement.

Trans-oral Endoscopic Restrictive Implant System: endoscopic treatment of obesity?

BACKGROUND: Endoscopic treatment of obesity might be an alternative to surgical treatment or, preoperatively, serve as an auxiliary therapy to surgery in patients at increased surgical risk. OBJECTIVE: To evaluate 6-month safety and efficacy of the Trans-Oral Endoscopic Restrictive Implant System (TERIS) as weight-loss device. SETTING: University hospital. METHODS: Patients 18-50 years with a body mass index (BMI) of 40-50 kg/m2 or 35-40 kg/m2 with obesity-related co-morbidities were eligible. Included patients underwent an endoscopic creation of a gastric pouch through attachment of a silicone restrictive implant to 5 cardia plications. Main outcome measurements were safety, expressed as serious adverse events and adverse events, and efficacy, expressed as percentage of excess weight loss (EWL), weight loss (WL), and excess BMI loss (EBMIL). RESULTS: Eighteen patients (3 males) with BMI of 42.1 kg/m2 (interquartile range 40.3-46.9) were included. Three serious adverse events occurred (2 pneumoperitoneum, 1 perforation). Adverse events subsided spontaneously or with medication. In 62.5% of patients, the anchors remained intact for 6 months. Presented as mean (±standard deviation), excess weight loss after 6 months was 30.1% (±9.8), weight loss was 15.1% (±5.3), and excess BMI loss was 37.7% (±12.4). In those who continued the study beyond the first 6 months, weight losses could only partially be maintained due to the detachment of anchors and the unimpeded passage of food. CONCLUSIONS: Three serious adverse events occurred in the first 7 patients. TERIS tolerability results improved after major changes in the system and the operating procedure. TERIS proved to be an effective 6-month treatment of obesity. As yet, because of the poor durability of the system, it cannot be recommended as a standalone endoscopic bariatric therapy. Therefore, the company decided to discontinue the TERIS system and to further develop the successful parts of it, such as the articulating circular endoscopic stapler.

Electromagnetic Guided Postpyloric Tube Placement in Children: A Feasible and Promising Technique.

OBJECTIVES: Postpyloric feeding tube (PPFT) placement can be cumbersome. Fluoroscopic and endoscopic placements are required when unguided placement fails. We aimed to evaluate the feasibility and safety of PPFT placement in children, using an electromagnetic (EM) guided system as a rescue strategy in case unguided tube insertion fails. METHODS: In a single-center prospective study, we included all the children (weight >2.5 kg) in whom unguided PPFT placement failed between 2009 and 2012. EM guided PPFT placement was attempted before regular fluoroscopic and endoscopic placement was attempted, respectively. RESULTS: Forty-nine children were included (mean age 3.5 years). EM guided PPFT placement was successful in 82% of the children. No adverse events occurred. Age or indication for the PPFT did not influence the success rate of the procedure. A trend of a learning curve of 25 patients was noticed. Costs of EM placement were slightly higher than those of fluoroscopic placement in our hospital setting. CONCLUSION: With enough expertise, EM guided PPFT placement seems safe and can prevent fluoroscopic or endoscopic tube placement in 82% of children.

Electromagnetic-Guided Versus Endoscopic Placement of Nasojejunal Feeding Tubes After Pancreatoduodenectomy: A Prospective Pilot Study.

OBJECTIVE: An altered anatomy such as after pancreatoduodenectomy is currently seen as relative contraindication for bedside electromagnetic (EM)-guided nasojejunal feeding tube placement. The aim of this study was to determine the feasibility and safety of bedside EM-guided placement of nasojejunal feeding tubes as compared with endoscopy in patients after pancreatoduodenectomy. METHODS: We performed a prospective monocenter pilot study in patients requiring enteral feeding after pancreatoduodenectomy (July 2012-March 2014). Primary end point was the success rate of primary tube placement confirmed on plain abdominal x-ray followed by successful enteral feeding. RESULTS: Overall, 53 (42%) of 126 patients who underwent pancreatoduodenectomy required a nasojejunal feeding tube, of which 36 were placed under EM guidance and, in 17, it was placed by endoscopy. Initial tube placement was successful in 21 (58%) of 36 patients with EM guidance and 9 (53%) of 17 patients with endoscopy (P = 0.71). No complications occurred during the placement procedures. Dislodgement and/or blockage of the tube occurred in 14 (39%) of 36 patients in the EM-guided group and 8 (47%) of 17 patients in the endoscopic group (P = 0.57). CONCLUSIONS: Bedside EM-guided placement of nasojejunal feeding tubes by nurses was equally successful as endoscopic placement in patients after pancreatoduodenectomy.

Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.

BACKGROUND: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs. METHODS/DESIGN: The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications. DISCUSSION: The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes. TRIAL REGISTRATION: Dutch Trial Register: NTR4420 , date registered 5-feb-2014.

Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis.

BACKGROUND & AIMS: Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial. METHODS: Patients with mild to moderately active UC (n = 50) were assigned to groups that underwent FMT with feces from healthy donors or were given autologous fecal microbiota (control); each transplant was administered via nasoduodenal tube at the start of the study and 3 weeks later. The study was performed at the Academic Medical Center in Amsterdam from June 2011 through May 2014. The composite primary end point was clinical remission (simple clinical colitis activity index scores ≤2) combined with ≥1-point decrease in the Mayo endoscopic score at week 12. Secondary end points were safety and microbiota composition by phylogenetic microarray in fecal samples. RESULTS: Thirty-seven patients completed the primary end point assessment. In the intention-to-treat analysis, 7 of 23 patients who received fecal transplants from healthy donors (30.4%) and 5 of 25 controls (20.0%) achieved the primary end point (P = .51). In the per-protocol analysis, 7 of 17 patients who received fecal transplants from healthy donors (41.2%) and 5 of 20 controls (25.0%) achieved the primary end point (P = .29). Serious adverse events occurred in 4 patients (2 in the FMT group), but these were not considered to be related to the FMT. At 12 weeks, the microbiota of responders in the FMT group was similar to that of their healthy donors; remission was associated with proportions of Clostridium clusters IV and XIVa. CONCLUSIONS: In this phase 2 trial, there was no statistically significant difference in clinical and endoscopic remission between patients with UC who received fecal transplants from healthy donors and those who received their own fecal microbiota, which may be due to limited numbers. However, the microbiota of responders had distinct features from that of nonresponders, warranting further study. ClinicalTrials.gov Number: NCT01650038.

Systematic review on bedside electromagnetic-guided, endoscopic, and fluoroscopic placement of nasoenteral feeding tubes.

BACKGROUND: Nasoenteral tube feeding is frequently required in hospitalized patients to either prevent or treat malnutrition, but data on the optimal strategy of tube placement are lacking. OBJECTIVE: To compare the efficacy and safety of bedside electromagnetic (EM)-guided, endoscopic, and fluoroscopic placement of nasoenteral feeding tubes in adults. DESIGN: Systematic review of the literature. PATIENTS: Adult hospitalized patients requiring nasoenteral feeding. INTERVENTIONS: EM-guided, endoscopic, and/or fluoroscopic nasoenteral feeding tube placement. MAIN OUTCOME MEASUREMENTS: Success rate of tube placement and procedure- or tube-related adverse events. RESULTS: Of 354 screened articles, 28 studies were included. Data on 4056 patients undergoing EM-guided (n = 2921), endoscopic (n = 730), and/or fluoroscopic (n = 405) nasoenteral feeding tube placement were extracted. Tube placement was successful in 3202 of 3789 (85%) EM-guided procedures compared with 706 of 793 (89%) endoscopic and 413 of 446 (93%) fluoroscopic procedures. Reinsertion rates were similar for EM-guidance (270 of 1279 [21%] patients) and endoscopy (64 of 394 [16%] patients) or fluoroscopy (10 of 38 [26%] patients). The mean (standard deviation) procedure time was shortest with EM-guided placement (13.4 [12.9] minutes), followed by endoscopy and fluoroscopy (14.9 [8.7] and 16.2 [23.6] minutes, respectively). Procedure-related adverse events were infrequent (0.4%, 4%, and 3%, respectively) and included mainly epistaxis. The tube-related adverse event rate was lowest in the EM-guided group (36 of 242 [15%] patients), followed by fluoroscopy (40 of 191 [21%] patients) and endoscopy (115 of 384 [30%] patients) and included mainly dislodgment and blockage of the tube. LIMITATIONS: Heterogeneity and limited methodological quality of the included studies. CONCLUSION: Bedside EM-guided placement of nasoenteral feeding tubes appears to be as safe and effective as fluoroscopic or endoscopic placement. EM-guided tube placement by nurses may be preferred over more costly procedures performed by endoscopists or radiologists, but randomized studies are lacking.

Prevalence of small-bowel neoplasia in Lynch syndrome assessed by video capsule endoscopy.

OBJECTIVE: The aim was to determine the prevalence of small-bowel neoplasia in asymptomatic patients with Lynch syndrome (LS) by video capsule endoscopy (VCE). DESIGN: After obtaining informed consent, asymptomatic proven gene mutation carriers aged 35-70 years were included in this prospective multicentre study in the Netherlands. Patients with previous small-bowel surgery were excluded. After bowel preparation, VCE was performed. The videos were read by two independent investigators. If significant lesions were detected, an endoscopic procedure was subsequently performed to obtain histology and, if possible, remove the lesion. RESULTS: In total, 200 patients (mean age 50 years (range 35-69), M/F 88/112), with proven mutations were included. These concerned MLH1 (n = 50), MSH2 (n = 68), MSH6 (n = 76), PMS2 (n = 3) and Epcam (n = 3) mutation carriers. In 95% of the procedures, caecal visualisation was achieved. Small-bowel neoplasia was detected in two patients: one adenocarcinoma (TisN0Mx) and one adenoma, both located in the duodenum. In another patient, a duodenal cancer (T2N0Mx) was diagnosed 7 months after a negative VCE. This was considered a lesion missed by VCE. All three neoplastic lesions were within reach of a conventional gastroduodenoscope. All patients with neoplasia were men, over 50 years of age and without a family history of small-bowel cancer. CONCLUSIONS: The prevalence of small-bowel neoplasia in asymptomatic patients with LS was 1.5%. All neoplastic lesions were located in the duodenum and within reach of conventional gastroduodenoscopy. Although VCE has the potential to detect these neoplastic lesions, small-bowel neoplasia may be missed. TRIAL REGISTRATION NUMBER: NCT00898768.

Outcomes of intragastric balloon placements in a private practice setting.

BACKGROUND AND STUDY AIM: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. PATIENTS AND METHODS: This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to three private centers for obesity treatment. RESULTS: A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m(2)). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon removal), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. CONCLUSION: In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surgery.

Endoscopic gastric volume reduction with a novel articulating plication device is safe and effective in the treatment of obesity (with video).

BACKGROUND: Endoscopic volume reduction of the stomach may provide a minimally invasive alternative for surgical procedures in the treatment of obesity. OBJECTIVE: To assess safety and preliminary effectiveness in the first human application of a novel endoscopic stapling technique. DESIGN: Prospective, observational, phase 1 study. SETTING: Two university hospitals in The Netherlands. PATIENTS: Patients with a body mass index (BMI) of 40 to 45 kg/m(2) or 30 to 39.9 kg/m(2) with obesity-related comorbidity. INTERVENTIONS: Gastric volume reduction with an endoscopic stapler. MAIN OUTCOME MEASUREMENTS: Primary outcome measure was the prevalence of serious or mild adverse events. Reduction of excess body weight after 12 months was assessed as a secondary outcome measure for effectiveness of the procedure. RESULTS: Seventeen patients with a median BMI of 40.2 kg/m(2) (interquartile range [IQR] 37.6-42.8) underwent an endoscopic stapling procedure. Median procedure time was 123 minutes (IQR 95-129). No serious adverse events occurred. Adverse events were gastric pain (n = 7, range 1-3 days), sore throat (n = 4, 2-3 days), diarrhea (n = 4, 2-15 days), nausea (n = 3, 2-4 days), constipation (n = 4, 3-14 days), and vomiting (n = 3, 1-4 days). All adverse events were mild and resolved with conservative treatment within 15 days after surgery. The median percentage excess weight loss in the first year was 34.9% (IQR 17.8-46.6). LIMITATIONS: Limited number of patients. CONCLUSION: This first human application of this endoscopic stapler demonstrates that the procedure is technically feasible and safe. One hundred sixty plications were created in 17 patients without significant problems. Weight loss after 1 year is promising, but long-term follow-up and randomized, controlled studies should evaluate whether this procedure is an effective and durable minimally invasive endoscopic treatment for obesity. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01429194.).

Endoscopic versus bedside electromagnetic-guided placement of nasoenteral feeding tubes in surgical patients.

BACKGROUND: Nasoenteral tube feeding is often required in surgical patients, mainly because of delayed gastric emptying. Bedside electromagnetic (EM)-guided tube placement by specialized nurses might offer several advantages (e.g., reduced patient discomfort and costs) over conventional endoscopic placement. The aim of this study was to compare the success rate of EM-guided to endoscopic placement of nasoenteral feeding tubes in surgical patients. MATERIALS AND METHODS: A retrospective cohort study was performed in 267 adult patients admitted to two gastrointestinal surgical wards who received a nasoenteral feeding tube by EM-guidance or endoscopy. Eighteen patients were excluded because of insufficient data. Patients were categorized according to the primary tube placement method. Subgroup analysis was performed in patients with altered upper gastrointestinal anatomy. Primary endpoint was successful tube placement at or beyond the duodenojejunal flexure. RESULTS: A total of 249 patients were included, of which 90 patients underwent EM-guided and 159 patients underwent endoscopic tube placement. Both groups were comparable for baseline characteristics. Primary tube placement was successful in 74/90 patients (82 %) in the EM-guided group versus 140/159 patients (88 %) in the endoscopic group (P = 0.20). In patients with altered upper gastrointestinal anatomy, success rates were significantly lower in the EM-guided group (58 vs. 86 %, P = 0.004). There were no significant differences in tube-related complications such as dislodgement or tube blockage. CONCLUSIONS: Bedside EM-guided placement of nasoenteral feeding tubes by specialized nurses did not differ from endoscopic placement by gastroenterologists regarding feasibility and safety in surgical patients with unaltered upper gastrointestinal anatomy.

Significant and safe shortening of the recovery time after flumazenil-reversed midazolam sedation.

BACKGROUND: Endoscopy under midazolam sedation requires a 2-h recovery facility. AIM: To study the potential of shortening patients' stay without jeopardizing patients' safety by the use of the benzodiazepine-antagonist flumazenil in the everyday practice and to investigate the feasibility of a study comparing midazolam with recovery with midazolam-flumazenil and immediate discharge. METHODS: Consecutive ambulatory patients referred for endoscopy under midazolam sedation with ASA I or II, escorted by a person, were eligible. Flumazenil was given on arrival in the recovery room. Patients were discharged when adequate Aldrete scores and physical mobility were present. The next day, they were contacted by telephone. RESULTS: A total of 1,506 patients participated. They received 5 mg midazolam, while 887 patients also received 50 mcg fentanyl. The median dose of flumazenil was 0.2 mg. Oxygen desaturation (sO2 <92%) occurred in 15% during the procedure without an effect on recovery and discharge times. Patients left the department 65 min after the last midazolam administration. The majority (82.7%) were fully alert during their journey home. At home, 2.7% went to bed, 45.2% took a nap, and 40% undertook activities. Almost every patient (98.8%) liked the shortened recovery time. Three patients had an incident (fainting, fall, and near-fall) without consequences. Based on this low incidence, a non-inferiority comparison of midazolam-flumazenil with midazolam-recovery would require a total of 32,650 patients. CONCLUSIONS: Administration of flumazenil resulted in a safe shortening of the recovery period and offers the possibility for substantial savings in time, space, and nurse resources. A non-inferiority comparison will not be practicable.

Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial.

BACKGROUND: Due to prophylactic colectomy, mortality in patients with familial adenomatous polyposis (FAP) has changed, with duodenal cancer currently being the main cause of death. Although celecoxib reduces duodenal polyp density in patients with FAP, its long-term use may increase the risk of cardiovascular events and alternatives need to be explored. Preclinical studies suggest that the combination of celecoxib with ursodeoxycholic acid (UDCA) is a potentially effective strategy. We performed a randomized, double-blind, placebo-controlled trial to investigate the effect of celecoxib and UDCA co-treatment on duodenal adenomatosis in patients with FAP. METHODS: Patients with FAP received celecoxib (400 mg twice daily) and UDCA (1000-2000 mg daily, ~20-30 mg/kg/day, n=19) or celecoxib and placebo (n=18) orally for 6 months. Primary outcome was drug efficacy, assessed by comparing duodenal polyp density at pre- and post-intervention by blinded review of endoscopic recordings. As secondary outcomes, cell proliferation, apoptosis, and COX-2 levels in normal duodenal mucosa were assessed by immunohistochemistry or real-time quantitative polymerase chain reaction. RESULTS: In intention-to-treat analysis, deceased polyp density was observed after celecoxib/placebo treatment (p=0.029), whereas increased polyp density was observed after celecoxib/UDCA treatment (p=0.014). The difference in change in duodenal polyp density was statistically significant between the groups (p=0.011). No changes in secondary outcomes were observed. Thirty patients (81%) reported one or more adverse events, 16 patients (84%, Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE) grade 1-3) treated with celecoxib/UDCA and 14 patients (78%, CTCAE grade 1-2) treated with celecoxib/placebo. Nine patients (24%) discontinued intervention prematurely, 5 patients (26%) treated with celecoxib/UDCA and 4 patients (22%) treated with celecoxib/placebo. CONCLUSIONS: Celecoxib reduces duodenal polyp density in patients with FAP, and unexpectedly, high dose UDCA co-treatment counteracts this effect. The benefit of long term use of celecoxib for duodenal cancer prevention needs to be weighed against the (risk of) adverse events. TRIAL REGISTRATION: http://ClinicalTrials.gov, identifier NCT00808743.