A. Aziz Aadam

In-vivo oesophageal regeneration in a human being by use of a non-biological scaffold and extracellular matrix

BACKGROUND Tissue-engineered extracellular matrix populated with autologous pluripotent cells can result in de-novo organogenesis, but the technique is complex, not widely available, and has not yet been used to repair large oesophageal defects in human beings. We aimed to use readily available stents and extracellular matrix to regenerate the oesophagus in vivo in a human being to re-establish swallowing function. METHODS In a patient aged 24 years, we endoscopically placed a readily available, fully covered, self-expanding, metal stent (diameter 18 mm, length 120 mm) to bridge a 5 cm full-thickness oesophageal segment destroyed by a mediastinal abscess and leading to direct communication between the hypopharynx and the mediastinum. A commercially available extracellular matrix was used to cover the stent and was sprayed with autologous platelet-rich plasma adhesive gel. The sternocleidomastoid muscle was placed over the matrix. After 4 weeks, stent removal was needed due to stent migration, and was replaced with three stents telescopically aligned to improve anchoring. The stents were removed after 3·5 years and the oesophagus was assessed by endoscopy, biopsy, endoscopic ultrasonography, and high-resolution impedance manometry. FINDINGS After stent removal we saw full-thickness regeneration of the oesophagus with stratified squamous epithelium, a normal five-layer wall, and peristaltic motility with bolus transit. 4 years after stent removal, the patient was eating a normal diet and maintaining a steady weight. INTERPRETATION Maintenance of the structural morphology of the oesophagus with off-the-shelf non-biological scaffold and stimulation of regeneration with commercially available extracellular matrix led to de-novo structural and functional regeneration of the oesophagus. FUNDING None.

A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy *

Background and study aims: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses. Patients and methods: Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy. Results: A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities. Conclusions: Results of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB.

Physician Assessment and Management of Complex Colon Polyps: A Multicenter Video-Based Survey Study

Objectives:The management of complex colorectal polyps varies in practice. Accurate descriptions of the endoscopic appearance by using a standardized classification system (Paris classification) and size for complex colon polyps may guide subsequent providers regarding curative endoscopic resection vs. need for surgery. The accuracy of this assessment is not well defined. Furthermore, the factors associated with decisions for endoscopic vs. surgical management are unclear. To characterize the accuracy of physician assessment of polyp morphology, size, and suspicion for malignancy among physician subspecialists performing colonoscopy and colon surgery. In addition, we aimed to assess the influence of these polyp characteristics as well as physician type and patient demographics on recommendations for endoscopic vs. surgical resection of complex colorectal polyps.Methods:An online video-based survey was sent to gastroenterologists (GIs) and gastrointestinal surgeons affiliated with six tertiary academic centers. The survey consisted of high-definition video clips (30–60 s) of six complex colorectal polyps (one malignant) and clinical histories. Respondents were blinded to histology. Respondents were queried regarding polyp characteristics, suspicion for malignancy, and recommendations for resection.Results:The survey response rate was 154/317 (49%). Seventy-eight percent of respondents were attending physicians (91 GIs and 29 surgeons) and 22% were GI trainees. Sixteen percent of respondents self-identified as specialists in complex polypectomy. Accurate estimation of polyp size was poor (28.4%) with moderate interobserver agreement (k=0.52). Accuracy for Paris classification was 47.5%, also with moderate interobserver agreement (k=0.48). Specialists in complex polypectomy were most accurate, whereas surgeons were the least accurate in assigning Paris classification (66.0 vs. 28.7%, P<0.0001). Specialists in complex polypectomy were most likely to correctly identify the malignant lesion compared with other physicians (87.5 vs. 56.2%, P=0.008). Surgical removal of colon adenomas was recommended least frequently by specialists in complex polypectomy (3.1%) compared with nonspecialists in complex polypectomy (13.3%); surgeons were most likely to recommend surgical resection (17.2%, P=0.009). There were no differences in recommendations for endoscopic vs. surgical resection observed on the basis of years in practice, polyp morphology (polypoid vs. nonpolypoid), polyp location (right vs. left colon), or patient ASA class.Conclusions:In this large survey of GIs and surgeons, physician specialty was strongly associated with accurate polyp characterization and a recommendation for endoscopic resection of complex polyps. Surgeons were most likely to recommend surgical resection of complex nonmalignant colorectal polyps compared with specialists in complex polypectomy who were the least likely. Therefore, collaboration with specialists in complex polypectomy may be helpful in determining the appropriate management of complex colon polyps. Further teaching is needed among all specialists to improve accurate communication and ensure optimal management of these lesions.

Enteral Stents in Malignant Bowel Obstruction

Colorectal stent placement offers a minimally invasive approach for relief of malignant bowel obstruction. Stent placement is safe and effective in carefully selected patients as a bridge to surgery or for definitive palliation of obstruction. Concerns remain regarding the long-term efficacy of stent placement and related complications. Future studies are needed to identify patients who are the best candidates for stent placement.

Aneurysm of the portal vein confluence diagnosed by endoscopic ultrasound

tion with establishment of pneumothorax was selected. A long esophagomyotomy was created without perforation of the mucosa (Fig. 1b), as confirmed by intraoperative endoscopy. The total length of the myotomy was 15 cm, the operation took 138 min and blood loss was approximately 25 mL. The patient experienced no postoperative complications, and the symptoms related to jackhammer esophagus were considerably improved. The hypercontractile segment was not detectable by HRM after the operation (Fig. 2b). Thirty two months after the operation, the surgery was proven effective without the need for additional treatment. To our knowledge, this is the first report to describe successful surgical treatment, using thoracoscopic esophageal long myotomy in the prone position, for a patient with jackhammer esophagus.

480 Efficacy of a Novel “UES Assist Device” in Management of Supraesophageal Complications of Reflux Disease: the Results of a Limited Clinical Trial

Background:Management of supraesophageal reflux disease complications of poses a significant clinical challenge. Acid suppressive therapy does not prevent volume refluxate into the pharynx and as such in a substantial percentage of these patients outcome of medical management has been disappointing. The efficacy of a novel “UES Assist Device” in preventing of simulated pharyngeal reflux in experimental setting have been recently reported. (Shaker et al. DDW 2010) The aim of the present study was to test the efficacy of the “UES Assist Device” in management of supraesophageal symptoms of reflux disease in a clinical trial. Method: We studied 14 patients with a variety of supraesophageal symptoms most notably chronic cough, excess phlegm and throat clearing referred from GI clinic in our institution. Participants filled out a detailed symptom questionnaire at baseline and following application of the device with randomly applied therapeutic and sub-therapeutic pressure assist. Symptoms were quantified using a 5-pont Likert scale. Each therapeutic modality was tested randomly for 7 days. Result: All patients tolerated the device well and completed the study. There were no complications or complaints for the use of the device. The global symptoms severity and impact score for therapeutic and sub-therapeutic pressure assist was significantly lower than that of the baseline. In addition, therapeutic pressure assist resulted in a significantly lower symptom severity compared to sub-therapeutic pressure assist (p=0.003 ANOVA) . (Figure) Furthermore, therapeutic pressure assist significantly decreased the most bothersome symptom compared to sub-therapeutic pressure assist (p<0.05). Conclusion: “UES Assist Device” is safe and effective in management of supraesophageal complications of reflux disease.

Multicenter evaluation of the clinical utility of laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass

BACKGROUND AND AIMS The obesity epidemic has led to increased use of Roux-en-Y gastric bypass (RYGB). These patients have an increased incidence of pancreaticobiliary diseases, yet standard ERCP is not possible because of surgically altered gastroduodenal anatomy. Laparoscopy-assisted ERCP (LA-ERCP) has been proposed as an option, but supporting data are derived from single-center small case series. Therefore, we conducted a large multicenter study to evaluate the feasibility, safety, and outcomes of LA-ERCP. METHODS This is a retrospective cohort study of adult patients with RYGB who underwent LA-ERCP in 34 centers. Data on demographics, indications, procedure success, and adverse events were collected. Procedure success was defined when all the following were achieved: reaching the papilla, cannulating the desired duct, and providing endoscopic therapy as clinically indicated. RESULTS A total of 579 patients (median age, 51; 84% women) were included. Indication for LA-ERCP was biliary in 89%, pancreatic in 8%, and both in 3%. Procedure success was achieved in 98%. Median total procedure time was 152 minutes (interquartile range [IQR], 109-210), with a median ERCP time of 40 minutes (IQR, 28-56). Median hospital stay was 2 days (IQR, 1-3). Adverse events were 18% (laparoscopy related, 10%; ERCP related, 7%; both, 1%) with the clear majority (92%) classified as mild/moderate, whereas 8% were severe and 1 death occurred. CONCLUSIONS Our large multicenter study indicates that LA-ERCP in patients with RYGB is feasible with a high procedure success rate comparable with that of standard ERCP in patients with normal anatomy. The ERCP-related adverse events rate is comparable with conventional ERCP, but the overall adverse event rate was higher because of the added laparoscopy-related events.

Su1095 Reflux Exposure Time on pH-Impedance Testing Predicts Symptom Improvement After Antireflux Surgery (ARS) Better Than Number of Reflux Events

pH-impedance testing detects reflux events irrespective of pH, and documents gastroesophageal reflux on proton pump inhibitor (PPI) therapy. However, impedance reflux parameters have not been well characterized, and predictors of symptom response after ARS are not known. Methods: All subjects with pre-ARS pH-impedance testing (Sandhill Scientific, Highlands Ranch, CO) over a 5-year period were evaluated. Subjects completed a symptom questionnaire preoperatively where dominant symptoms were identified and scored, and global symptom severity (GSS) was recorded on a 100-mm visual analog scale (VAS). Acid reflux parameters evaluated included acid exposure time (AET, % time pH 4%), symptom association probability calculated with the Ghillebert probability estimate (GPE), and symptom index (SI). Impedance reflux parameters included reflux exposure time (RET, % time refluxate is in contact with impedance electrodes 5 cm above LES corresponding to AET, abnormal>1.4%), GPE, and SI (both with impedance data). Subjects were prospectively contacted, and dominant and global symptom scores repeated to correspond to the pre-ARS questionnaire. Univariate and multivariate analyses were performed to determine predictors of GSS change after ARS. Results: Over the study period 56 subjects (54.7 ±9.2 yrs, 78.6% female) were contacted who underwent ARS. Symptom duration was 6 (0.5-20) yrs, with baseline GSS of 65.9 ±3.4 on VAS; 40 (71.4%) had typical symptoms (heartburn=20, regurgitation=20) and 16 had atypical symptoms (cough=10, chest pain=4, other=2). ARS improved symptoms by 51.3 ±4.6 on VAS (p <0.001 vs pre-ARS global symptoms) after follow up of 2.3 (1.2-6.4) yrs. On univariate analysis, AET (B=1.5, p=0.03), acid GPE (B=16.32, p=0.08), RET (B=1.63, p=0.07), impedance SI (B=24.4, p=0.008) and acid SI (B=13.71, p=0.16) all trended towards predicting post-ARS GSS improvement. When controlling for PPI status during testing, RET significantly predicted post-ARS symptom improvement (B=2.41, p=0.036) in tests performed on therapy, and trended towards predicting symptom improvement off therapy (B=3.06, p=0.11); numbers of reflux events did not predict improvement using established thresholds. Both AET and RET performed better with typical symptoms (p=0.05 and 0.047 respectively) than with atypical symptoms (p= ns for both). On multivariate linear regression controlling for age, gender, PPI status and dominant symptom pattern, RET independently predicted postoperative GSS (p=0.005); AET was also an independent predictor (p=0.004). SI calculated from impedance reflux trended towards significance (p=0.05), but currently utilized thresholds for numbers of reflux events did not. Conclusion: Reflux exposure time is a useful parameter in pHimpedance testing, with better predictive value for symptom improvement than total number of reflux events.