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EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes?
Patel, N, Mohanaruban, A, Ashrafian, H, Le Roux, C, Byrne, J, Mason, J, Hopkins, J, Kelly, J, Teare, J
Obesity surgery. 2018;(7):1980-1989
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Abstract
BACKGROUND AND AIMS Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30-50 kg/m2 and HbA1c levels of 7.5-10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. RESULTS Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62-29.38; p < 0.05) and BMI (95%CI 1.1-8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1-1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. CONCLUSIONS The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
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Efficacy of percutaneous endoscopic gastro-jejunostomy (PEG-J) decompression therapy for patients with chronic intestinal pseudo-obstruction (CIPO).
Ohkubo, H, Fuyuki, A, Arimoto, J, Higurashi, T, Nonaka, T, Inoh, Y, Iida, H, Inamori, M, Kaneda, T, Nakajima, A
Neurogastroenterology and motility. 2017;(12)
Abstract
BACKGROUNDS Chronic intestinal pseudo-obstruction (CIPO) is an intractable rare digestive disease manifesting persistent small bowel distension without any mechanical cause. Intestinal decompression is a key treatment, but conventional method including a trans-nasal small intestinal tube is invasive and painful. Therefore, a less invasive and tolerable new decompression method is urgently desired. We conducted a pilot study and assessed the efficacy and safety of percutaneous endoscopic gastro-jejunostomy (PEG-J) decompression therapy in CIPO patients. METHODS Seven definitive CIPO patients (2 males and 5 females) were enrolled. All patients received PEG-J decompression therapy. The number of days with any abdominal symptoms in a month (NODASIM), body mass index (BMI), serum albumin level (Alb), and small intestinal volume before and after PEG-J were compared in all patients. RESULTS Percutaneous endoscopic gastro-jejunostomy was well tolerated and oral intake improved in all patients. NODASIM has significantly decreased (24.3 vs 9.3 days/months) and BMI/Alb have significantly increased (14.9 vs 17.2 kg/m2 and 2.6 vs 3.8 g/dL, respectively), whereas total volume of the small intestine has not significantly reduced (4.05 vs 2.59 L, P=.18). Reflux esophagitis and chemical dermatitis were observed in one case but was successfully treated conservatively. CONCLUSIONS & INFERENCES Percutaneous endoscopic gastro-jejunostomy decompression therapy can contribute greatly to improvement of abdominal symptoms and nutritional status in CIPO patients. Although sufficient attention should be paid to acid reflux symptoms, PEG-J has the potential to be a non-invasive novel decompression therapy for CIPO available at home. However, accumulation of more CIPO patients and long-term observation are needed (UMIN000017574).
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A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study.
Kim, KJ, Victor, D, Stein, E, Valeshabad, AK, Saxena, P, Singh, VK, Lennon, AM, Clarke, JO, Khashab, MA
Gastrointestinal endoscopy. 2013;(1):154-7
Abstract
BACKGROUND The tip of currently available percutaneous endoscopic gastrojejunostomy (PEGJ) tubes frequently migrates back into the stomach. OBJECTIVE To study the safety of a novel, ballooned-tip, PEGJ tube and assess the risk of retrograde migration into the stomach within 3 weeks of placement. DESIGN Prospective clinical study (NCT01551095). SETTING Tertiary-care center. PATIENTS Seven patients who required post-pyloric feeding were included. INTERVENTION Placement of PEGJ feeding tubes. MAIN OUTCOME MEASUREMENTS Position of the PEGJ, abdominal radiograph findings, adverse events. RESULTS Seven patients underwent placement of self-propelled PEGJ tubes during the study period. Technical success was achieved in all patients (100%). All procedures were rated as technically simple, and jejunostomy tubes were placed in <5 minutes during all procedures. Abdominal radiographs showed that the jejunostomy tubes were in the jejunum in all 7 patients at both 1 and 3 weeks after tube placement. LIMITATIONS Small number of patients and short follow-up. CONCLUSION Ballooned-tip PEGJ feeding tubes were safe and easy to place. The presence of the balloon prevented migration into the stomach. Ballooned-tip PEGJ tubes have the potential to eliminate the need for hospital readmission and repeat endoscopies for retrograde tube migration, and this may result in large systemic cost savings.
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One-step percutaneous gastrojejunostomy in early infancy.
Michaud, L, Robert-Dehault, A, Coopman, S, Guimber, D, Turck, D, Gottrand, F
Journal of pediatric gastroenterology and nutrition. 2012;(6):820-1
Abstract
In certain conditions that obviate the use of gastric feedings, the insertion of a jejunal feeding tube via gastrostomy constitutes an alternative to jejunostomy but requires a preexisting gastrostomy. Our aim was to assess a new technique of 1-step gastrojejunal tube insertion through a de novo gastrostomy. A total of 3 infants between 3 and 7 months old and weighing between 4.1 and 5.4 kg had a gastrojejunal feeding tube inserted using a 16-CH French introducer percutaneous endoscopic gastrostomy kit and a transgastric-jejunal feeding tube. No technical difficulties occurred and the gastrojejunal feeding tube was placed successfully in the 3 patients, the total procedure lasting 15 to 20 minutes. Enteral feeding was started within 4 to 6 hours of the procedure. Neither immediate (<24 hours) nor late complications related to the gastrojejunostomy occurred. Nissen fundoplication was performed in 2 of our patients at 12 and 15 months of age, respectively. The gastrojejunostomy tube was still in place in the third patient at age 15 months. Our first experience suggests that 1-step endoscopic placement of a transgastric-jejunal feeding tube without a preexisting gastrostomy tract is feasible in young and low-weight infants.
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Is it proper to use non-magnified narrow-band imaging for esophageal neoplasia screening? Japanese single-center, prospective study.
Yokoyama, A, Ichimasa, K, Ishiguro, T, Mori, Y, Ikeda, H, Hayashi, T, Minami, H, Hayashi, S, Watanabe, G, Inoue, H, et al
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society. 2012;(6):412-8
Abstract
AIM: Most screening examinations in Japanese general hospitals are carried out by high-definition television-incompatible (non-HD) scopes and non-magnifying endoscopes. We evaluated the narrow-band imaging (NBI) real-time diagnostic yield of esophageal neoplasia in high-risk patients at a general hospital. METHODS In a single-center, prospective, non-randomized controlled trial, 117 consecutive screening patients with high risk for esophageal cancer received primary white-light imaging (WLI) followed by NBI and iodine-staining endoscopy (59 by HDTV-compatible [HD] endoscopy and 58 by non-HD endoscopy). The primary aim was to evaluate the diagnostic yield of non-magnified images in diagnosing esophageal neoplasia. The secondary aim was to compare HD endoscopy and non-HD endoscopy in terms of diagnostic performance. RESULTS Overall, the sensitivity of NBI for screening of esophageal neoplasia was superior to WLI, and equivalent to iodine staining (92% vs 42%; P < 0.05, 92% vs 100%; ns). The specificity of NBI was equivalent to WLI (89% vs 94%; ns). In HD, NBI sensitivity was equivalent to both iodine staining and WLI (100% vs 75%; ns). In non-HD, NBI sensitivity was equivalent to iodine staining, but WLI sensitivity was significantly inferior to NBI (88% vs 100%; ns, 25% vs 88%; P < 0.05). The NBI specificity was equivalent to WLI not only in HD but also in non-HD (90% vs 96%; ns, 88% vs 93%; ns). CONCLUSION In both HD and non-HD endoscopy, NBI is less likely than WLI to miss a lesion. Even with non-HD endoscopy, NBI is suitable for esophageal standard examinations in general hospitals.
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Use of direct, endoscopic-guided measurements of mucosal impedance in diagnosis of gastroesophageal reflux disease.
Saritas Yuksel, E, Higginbotham, T, Slaughter, JC, Mabary, J, Kavitt, RT, Garrett, CG, Vaezi, MF
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2012;(10):1110-6
Abstract
BACKGROUND & AIMS Diagnostic tests for gastroesophageal reflux disease (GERD) are constrained because measurements are made at a single time point, so the long-term effects on the mucosa cannot be determined. We developed a minimally invasive system to assess changes in esophageal mucosal impedance (MI), a marker of reflux. We measured the extent of changes in MI along the esophagus and show that the device to assess MI can be used to diagnose patients with GERD. METHODS A single-channel MI catheter composed of a unique sensor array was designed to easily traverse the working channel of an upper endoscope. We performed a prospective longitudinal study of patients with erosive esophagitis (n = 19), nonerosive but pH-positive GERD (n = 23), and those without GERD (n = 27). MI was measured at the site of esophagitis as well as 2, 5, and 10 cm above the squamocolumnar junction. The MI values were compared among groups, at different levels along the esophageal axis. RESULTS Median MI values were significantly lower at the site of erosive mucosa (811 Ω; range, 621-1272 Ω) than other nonerosive regions (3723 Ω; range, 2421-4671 Ω; P = .001), and were significantly lower at 2 cm above the squamocolumnar junction in patients with GERD (2096 Ω; range, 1415-2808 Ω), compared with those without GERD (3607 Ω; range, 1973-4238 Ω; P = .008). There was a significant and graded increase in MI along the axis of the distal to proximal esophagus in patients with GERD that was not observed in individuals without reflux (P = .004). CONCLUSIONS Measurements of MI along the esophagus can be used to identify patients with GERD. ClinicalTrials.gov, number NCT01194323.
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Human experience with an endoluminal, endoscopic, gastrojejunal bypass sleeve.
Sandler, BJ, Rumbaut, R, Swain, CP, Torres, G, Morales, L, Gonzales, L, Schultz, S, Talamini, M, Horgan, S
Surgical endoscopy. 2011;(9):3028-33
Abstract
BACKGROUND This report describes the authors' experience with a unique endoluminal, endoscopically delivered and retrieved gastroduodenojejunal bypass sleeve, including short-term weight loss and changes in comorbidities. METHODS A prospective, single-center trial was designed. The patients were morbidly obese individuals who met the National Institutes of Health criteria for bariatric surgery. The device used was a unique gastroduodenojejunal bypass sleeve secured at the esophagogastric junction with endoscopic and laparoscopic techniques and designed to create an endoluminal gastroduodenojejunal bypass. At completion of the trial, the device was explanted with endoscopic retrieval. The primary end points were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in comorbidities, specifically glucose control, use of antihyperglycemic medications, and changes in hemoglobin A1c levels. RESULTS From July 2008 to February 2010, 24 patients were enrolled in the trial. The gastroduodenojejunal bypass sleeve was implanted, left in situ, and then retrieved. The 7 men and 17 women in the study had a mean preoperative body mass index of 42 kg/m(2). The device was successfully delivered in 22 of the 24 patients (92%) and retrieved endoscopically from all 22 patients in whom it was implanted (100%). Two patients were excluded from the study preprocedurally. The one patient was excluded preoperatively due to noncompliance with the preoperative liquid diet. For the other excluded patient, the device was not attempted endoscopically due to significant inflammation at the gastroesophageal junction at the time of laparoscopic evaluation. Of the 22 patients who had the device implanted, 17 maintained it (77%) and completed the full 12-week trial. These patients had 39.7% excess weight loss at completion of the study. The primary reason for early explantation of the device was early postoperative dysphagia. The seven patients with preoperative diabetes mellitus all had normal blood glucose levels throughout the trial, and none required antihyperglycemic medications. All four patients with elevated hemoglobin A1c levels preoperatively showed improvement by the end of the trial. CONCLUSIONS This trial demonstrated that the endoluminal gastroduodenojejunal sleeve can achieve excellent weight loss at 12 weeks. No patient safety issues were encountered. Adverse effects were minimal and resolved at endoscopic device removal. Effective glycemic control was demonstrated through use of the device during the trial. Long-term results are needed.
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Evaluation of gastrointestinal pathology and treatment in children with suspected biliary dyskinesia.
Karnsakul, W, Vaughan, R, Kumar, T, Gillespie, S, Skitarelic, K
Pediatric surgery international. 2011;(12):1307-12
Abstract
AIM: Decreased gallbladder ejection fraction (GBEF) was reported in patients who had abdominal pain and gastrointestinal (GI) diseases. The study aims were to review pathology of GI tract in children with acalculous biliary-type abdominal pain and to evaluate the pain improvement after a 2-week trial of proton pump inhibitor (PPI) and laparoscopic cholecystectomy (LC). METHODS Children below 18 years of age with a history of biliary-type abdominal pain by ROME III criteria were evaluated. All underwent an upper endoscopy and their histologic findings of the proximal GI tract were reviewed. Responses to a 2-week trial of PPI and LC were analyzed. RESULTS Sixteen were identified with biliary-type abdominal pain with GBEF <35%. Endoscopic and histologic evidence of reflux esophagitis was observed in 11 children those of gastritis in 3 children. A GI pathology of these children is mostly acid-related and four of ten children experienced a complete response to PPIs and did not require LC. Nine children had LC; four had complete and four had partial pain improvement. CONCLUSION A trial of PPIs may be cost-effective prior to considering LC in these patients since four of ten children experienced a complete response to PPIs without the requirement of LC, compared with four of nine children who improved completely.
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A prospective study of same day bi-directional endoscopy in the evaluation of patients with occult gastrointestinal bleeding.
Stray, N, Weberg, R
Scandinavian journal of gastroenterology. 2006;(7):844-50
Abstract
OBJECTIVE Previous studies show conflicting results in the diagnostic yield of oesophagogastroduodenoscopy (OGD) and colonoscopy (bi-directional) in identifying potential bleeding sources (PBS) in patients investigated for occult gastrointestinal bleeding (OGIB). The aims of this study were to evaluate the diagnostic yield of bi-directional endoscopy in patients presenting with OGIB and to assess the factors predictive of a positive yield. MATERIAL AND METHODS Patients with OGIB referred to the gastroenterology unit were prospectively included in the study. Colonoscopy was immediately followed by OGD. Predetermined criteria for the diagnosis of a PBS were used. Potential clinical factors predictive of positive yield were assessed. RESULTS Of the 219 patients (mean age 65 years, 34% M), 110 (50%) had at least one PBS. Colonoscopy revealed 87 PBS in 73 patients (33%), the most common being adenoma. OGD detected 49 PBS in 48 patients (22%), gastric ulcer being the most common. Of the patients with PBS at OGD, 23% also had a PBS at colonoscopy, including 3 patients with colonic cancers. Patients presenting with either a positive faecal occult blood test (FOBT) or iron-deficiency anaemia (IDA) only had a significantly lower yield for PBS than patients with combined positive FOBT and IDA. The percentages of patients with a PBS increased substantially with age. CONCLUSIONS A PBS was found in only 50% of the patients. Colonoscopy had a slightly higher diagnostic yield, and as expected, resulted in a significantly higher cancer detection rate than OGD. In older patients, colonoscopy should be done irrespective of the findings at OGD. Gastrointestinal-specific symptoms and the use of ASA/NSAIDs were not predictive in finding or localizing PBS.
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Morbidity and mortality after percutaneous endoscopic gastrostomy in children with neurological disability.
Catto-Smith, AG, Jimenez, S
Journal of gastroenterology and hepatology. 2006;(4):734-8
Abstract
BACKGROUND AND AIM Gastrostomy placement has become an integral mechanism for delivering nutritional support to children with severe neurological disability. Its impact on gastroesophageal reflux and mortality remains contentious. We examined the morbidity and long-term mortality of a group of children with severe neurological disability after percutaneous endoscopic gastrostomy (PEG). METHODS We retrospectively identified all children with severe neurological disability who had a PEG at the Royal Children's Hospital in Melbourne between 1990 and 1997. Data were obtained from medical records. RESULTS Ninety-eight children with neurological disability (M:F 1.8:1.0; median age 3.5 years, interquartile range 1.1-8.7 years) had an initial PEG in this period and were able to be followed for 6-14 years. As a group, they were underweight for their age with a Z score at PEG of -3.52 (SD 3.33), but had increased weight-for-age Z scores by 1.05 after a mean period of 6.1 months. Fourteen subsequently required fundoplication for reflux. Mortality rates were 11% after 1 year, 21% after 2 years, 27% after 3 years and 39% after 13 years. Mortality was increased in those children who were older at the time of PEG (P = 0.06). Gastroesophageal reflux, underweight-for-age and gender were not significantly related to mortality. CONCLUSION Children with severe neurological dysfunction who require gastrostomy feeding have a substantial long-term mortality, but this may be unrelated to PEG placement.