Randomized trial of gastric and colorectal endoscopic submucosal dissection defect closure comparing a novel through-the-scope suturing system with an over-the-scope suturing system (with video).

BACKGROUND AND AIMS: Mucosal closure adds time but reduces adverse events associated with endoscopic submucosal dissection (ESD). We aimed to assess the closure time (CT), technical success, and cost-effectiveness between a novel through-the-scope helix tack suture system (TTSS) and the over-the-scope suturing system (OTSS). METHODS: In this single-center, prospective, randomized trial, all patients undergoing ESD with anticipated closure were randomized 1:1 to TTSS (study group) or OTSS (control group). Primary outcomes were CT and overall CT (OCT; CT + setup time). Secondary outcomes were rates of technical success, adverse events, and cost-effectiveness. RESULTS: Forty patients were randomized to OTSS (n = 20) or TTSS (n = 20). OTSS and TTSS groups were similar with respect to age, gender, proportion of colorectal polyps, proximal colon polyps, and mean size of the resected specimen (40.9 mm vs 40.4 mm). The mean CT was 18.4 minutes for OTSS and 23.3 minutes for TTSS (P = .36). The mean OCT was 32 minutes for OTSS and 39.5 minutes for TTSS (P = .36). Closure with a primary device was successful in 17 cases (85%) with OTSS and 18 cases (90%) with TTSS (P = .63). No closure-related intraprocedural adverse events or delayed perforations were noted. Mean cost of closure was significantly lower in the TTSS group for lesions <35 mm (P = .008). CONCLUSIONS: TTSS was not found to be superior to OTSS with respect to CT and technical and clinical success for closure of gastric and colorectal ESD defects. TTSS is more cost-effective for closure of lesions <35 mm. (Clinical trial registration number: NCT04925271.).

EUS imaging for the diagnosis of nonalcoholic fatty liver disease.

BACKGROUND AND AIMS: EUS is increasingly used to evaluate patients with liver disease, but its role in assessing hepatic steatosis has not been reported. The goal of our study was to assess the accuracy of EUS for diagnosing hepatic steatosis. METHODS: We identified all patients who underwent EUS-guided liver biopsy sampling at our institution. All digitally stored EUS liver images were reviewed by a single radiologist, who rated the severity of liver echogenicity using a 4-point US scale. Liver biopsy specimens for all study patients were reviewed by a single liver pathologist, who rated them for steatosis and fibrosis using Nonalcoholic Steatohepatitis Clinical Research Network criteria. Receiver operator characteristic curves were used to assess the diagnostic accuracy of EUS for hepatic steatosis for all patients and in a subgroup analysis for obese and nonobese patients. RESULTS: During the study period, 76 patients underwent EUS-guided liver biopsy sampling. The average age of study patients was 56.5 years, 50% were women, and 43.2% were obese. The accuracy for EUS for the diagnosis of hepatic steatosis was .8 (95% confidence interval [CI], .7-.89). The accuracy of EUS for the diagnosis of hepatic steatosis in obese patients was .93 (95% CI, .8-.99) and in nonobese patients was .69 (95% CI, .54-.83). For obese patients, EUS had a positive predictive value of 89.7% and a negative predictive value of 75%. The finding of course echotexture on EUS had an accuracy of 79% for the diagnosis of grade 3 fibrosis or cirrhosis. CONCLUSIONS: EUS is a useful tool for the diagnosis of hepatic steatosis, particularly in obese patients in whom abdominal US has modest accuracy.

Outcomes after endoscopic retrograde cholangiopancreatography with general anaesthesia versus sedation.

BACKGROUND: We tested the primary hypothesis that use of general anaesthesia vs sedation increases vulnerability to adverse discharge (in-hospital mortality or new discharge to a nursing facility) after endoscopic retrograde cholangiopancreatography (ERCP). METHODS: In this retrospective cohort study, adult patients undergoing ERCP with general anaesthesia or sedation at a tertiary care hospital were included. We calculated adjusted absolute risk differences between patients receiving general anaesthesia vs sedation using provider preference-based instrumental variable analysis. We also used mediation analysis to determine whether intraoperative hypotension during general anaesthesia mediated its effect on adverse discharge. RESULTS: Among 17 538 patients undergoing ERCP from 2007 through 2018, 16 238 received sedation and 1300 received GA. Rates of adverse discharge were 5.8% (n=938) after sedation and 16.2% (n=210) after general anaesthesia. Providers' adjusted mean predicted probabilities of using general anaesthesia for ERCP ranged from 0.2% to 63.2% of individual caseloads. Utilising provider-related variability in the use of general anaesthesia for instrumental variable analysis resulted in an 8.6% risk increase (95% confidence interval, 4.5-12.6%; P<0.001) in adverse discharge among patients receiving general anaesthesia vs sedation. Intraoperative hypotensive events occurred more often during general anaesthesia and mediated 23.8% (95% confidence interval, 3.9-43.7%: P=0.019) of the primary association. CONCLUSIONS: These results suggest that use of sedation during ERCP facilitates reduced adverse discharge for patients for whom general anaesthesia is not clearly indicated. Intraoperative hypotension during general anaesthesia for ERCP partly mediates the increased vulnerability to adverse discharge.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy.

BACKGROUND: The duration of treatment of gastrointestinal tuberculosis continues to be a matter of debate. The World Health Organization advocates intermittent directly observed short-course therapy (DOTs), but there is a lack of data of its efficacy in abdominal tuberculosis. We therefore conducted a multicenter randomized controlled trial to compare 6 months and 9 months of antituberculosis therapy using DOTs. METHODS: One hundred ninety-seven patients with abdominal tuberculosis (gastrointestinal, 154; peritoneal, 40; mixed, 3) were randomized to receive 6 months (n = 104) or 9 months (n = 93) of antituberculosis therapy using intermittent directly observed therapy. Patients were followed up 1 year after completion of treatment to assess recurrence. Patients were evaluated for primary endpoint (complete clinical response, partial response, and no response) and secondary endpoint (recurrence of the disease at the end of 1 year of follow-up). RESULTS: Baseline characteristics were similar between the 2 randomized groups. There was no difference between the 6-month group and 9-month group in the complete clinical response rate on per-protocol analysis (91.5% vs 90.8%; P = .88) or intent-to-treat analysis (75% vs 75.8%; P = .89). Only 1 patient in the 9-month group and no patients in the 6-month group had recurrence of disease. Side effects occurred in 21 (21.3%) and 16 (18.2%) patients in the 6-month and 9-month groups, respectively. CONCLUSIONS: There was no difference in efficacy of antituberculosis therapy delivered for either 6 months or 9 months in either gastrointestinal or peritoneal tuberculosis, confirming the efficacy of intermittent directly observed therapy. CLINICAL TRIALS REGISTRATION: NCT01124929.

Titers of anti-tissue transglutaminase antibody correlate well with severity of villous abnormalities in celiac disease.

GOALS: We reviewed our celiac disease (CeD) database to study if anti-tissue transglutaminase (tTG) antibody (ab) titers correlate with severity of villous abnormalities in Indian patients and to find out a cutoff value of anti-tTG ab fold-rise, which could best predict CeD. BACKGROUND: Guidelines for diagnosing CeD suggest that biopsy could be avoided in some patients with high anti-tTG ab titer. STUDY: We reviewed a cohort of 366 anti-tTG ab-positive individuals in whom duodenal biopsies were performed. Anti-tTG ab was obtained before initiation of gluten-free diet. Anti-tTG ab results were expressed in terms of fold-rise by calculating ratio of observed values with cutoff value. CeD was diagnosed if in addition to positive serology, patients had villous atrophy (>Marsh grade 2) and unequivocal response to gluten-free diet. RESULTS: The mean anti-tTG fold-rise in groups with Marsh grade ≤2 was 2.6 (±2.5), grade 3a was 4.0 (±3.9), 3b was 5.7 (±5.1), and 3c was 11.8 (±8.0). The positive likelihood ratio for diagnosing CeD was 15.4 and 27.4 at 12- and 14-fold-rise of anti-tTG ab titer, respectively. The positive predictive value of diagnosis of CeD was 100% when anti-tTG ab titer was 14-fold higher over the cutoff value. Fifty-seven (43.9%) individuals with anti-tTG titer rise <2-fold high also had CeD. CONCLUSIONS: As severity of villous abnormality increases, titer of anti-tTG also rises. Presence of villous atrophy can be predicted at very high anti-tTG ab titer. In contrast to emerging belief, mucosal biopsies should be performed even if anti-tTG ab titer is <2 times, because many patients with CeD have low titers.

Coeliac disease in patients with short stature: A tertiary care centre experience.

BACKGROUND: We aimed to determine the prevalence of coeliac disease among children with short stature at a tertiary care centre and to define the predictors for coeliac disease, if any, in them. METHODS: In this retrospective study, we reviewed the case records of children and adolescents with growth retardation attending the Paediatric Endocrinology Clinic from January 2008 to June 2011. All patients underwent the multi-tier stratified diagnostic protocol for complete evaluation of short stature. Coeliac disease was screened using IgA-anti-tissue transglutaminase antibody. The diagnosis of coeliac disease was made on the basis of the modified European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria. RESULTS: Of 432 patients (238 boys) who presented with short stature, 72 (16.7%) had physiological, while 360 (83.3%) had pathological causes. Endocrine causes were growth hormone deficiency (86 patients, 19.9%), hypopituitarism (31, 7.2%), hypothyroidism (22, 5.1%) and others (7, 1.6%). The systemic causes were: coeliac disease (47, 10.9%), haematological diseases (14, 3.2%), renal diseases (11, 2.5%) and others (24, 5.6%). Chronic diarrhoea (OR 15.7, 95% CI 7.8-31.5) and anaemia (OR 4.9, 95% CI 1.9-12.7]) were significant predictors for coeliac disease in patients with short stature. There was a definite response to gluten-free diet in them and the mean (SD) growth velocity measured over at least 6 months of gluten-free diet was 8.1 (3.0) cm/year. CONCLUSION: Nearly 11% of patients presenting with short stature have coeliac disease. In these patients chronic diarrhoea and anaemia were significant predictors of coeliac disease.

Clip Dislodgement After Full-Thickness Endoscopic Resection Device Removal of Scarred Gastric Subepithelial Lesion Leading to Delayed Perforation.

Endoscopic full-thickness resection using a full-thickness resection device is a newer technique for endoscopic removal of submucosal lesions not amenable to endoscopic mucosal resection or endoscopic submucosal dissection. There is a low rate of complications reported, although we report 2 cases of delayed perforation caused by dislodgement of a full-thickness resection device clip after removal of scarred gastric lesions. Both were managed endoscopically with good outcomes. However, special attention and consideration of alternative closure techniques should be considered with scarred gastric lesions and possible changes to the clip design could be considered.

Impact of COVID-19 on gastroenterology fellowship training: a multicenter analysis of endoscopy volumes.

Background and study aims The COVID-19 pandemic has had a profound impact on gastroenterology training programs. We aimed to objectively evaluate procedural training volume and impact of COVID-19 on gastroenterology fellowship programs in the United States. Methods This was a retrospective, multicenter study. Procedure volume data on upper and lower endoscopies performed by gastroenterology fellows was abstracted directly from the electronic medical record. The study period was stratified into 2 time periods: Study Period 1, SP1 (03/15/2020 to 06/30/2020) and Study Period 2, SP2 (07/01/2020 to 12/15/2020). Procedure volumes during SP1 and SP2 were compared to Historic Period 1 (HP1) (03/15/2019 to 06/30/2019) and Historic Period 2 (HP2) (07/01/2019 to 12/15/2019) as historical reference. Results Data from 23 gastroenterology fellowship programs (total procedures = 127,958) with a median of 284 fellows (range 273-289; representing 17.8 % of all trainees in the United States) were collected. Compared to HP1, fellows performed 53.6 % less procedures in SP1 (total volume: 28,808 vs 13,378; mean 105.52 ±â€Š71.94 vs 47.61 ±â€Š41.43 per fellow; P  < 0.0001). This reduction was significant across all three training years and for both lower and upper endoscopies ( P  < 0.0001). However, the reduction in volume was more pronounced for lower endoscopy compared to upper endoscopy [59.03 % (95 % CI: 58.2-59.86) vs 48.75 % (95 % CI: 47.96-49.54); P  < 0.0001]. The procedure volume in SP2 returned to near baseline of HP2 (total volume: 42,497 vs 43,275; mean 147.05 ±â€Š96.36 vs 150.78 ±â€Š99.67; P  = 0.65). Conclusions Although there was a significant reduction in fellows' endoscopy volume in the initial stages of the pandemic, adaptive mechanisms have resulted in a return of procedure volume to near baseline without ongoing impact on endoscopy training.

Endoscopic suturing for the management of recurrent dislodgment of percutaneous endoscopic gastrostomy-jejunostomy tube.

OBJECTIVE: To describe a novel technique for the prevention of recurrent percutaneous endoscopic gastrostomy-jejunostomy (PEG-J) tube dislodgements and assess its feasibility and efficacy. This technique utilizes endoscopic suturing to secure the PEG-J tube to the gastric wall. METHODS: This was a retrospective analysis of consecutive cases of recurrent PEG-J tube dislodgements referred to a single endoscopist between June 2016 and June 2017, using an endoscopic suturing system to secure the PEG-J tube directly to the gastric wall. Technical success rates, the procedure time and related adverse events were analyzed. RESULTS: There were five patients in total (three females). The procedure was technically successful in all patients. There were no procedure-related adverse events. The mean duration of follow-up was 7.8 ± 5.1 months. Two patients had accidental dislodgement at 8.5 and 12 months, respectively. There were no other unintended dislodgements. CONCLUSION: Endoscopic suturing with internal fixation of PEG-J tube is a safe and feasible approach to manage recurrent unintended dislodgements.

Inversion Technique for the Removal of Partially Covered Self-Expandable Metallic Stents.

BACKGROUND AND AIMS: Partially covered self-expandable metallic stents (PCSEMS), although an effective treatment for anastomotic/staple line leaks and strictures, can be difficult to remove. This study examines the effectiveness of the inversion technique for the removal of PCSEMS in the treatment of leaks and strictures that occurred post-sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). METHODS: Consecutive patients who underwent PCSEMS removal for a leak and/or stricture post-SG or RYGB between July 2013 and December 2016 at the Johns Hopkins Medical Institutions were reviewed. All PCSEMS removals were first attempted via the inversion technique, which involves grasping the distal end of the stent and inverting it through itself. RESULTS: Fourteen patients (four males) underwent PCSEMS removal via the inversion technique for an anastomotic/staple line leak (50%), stricture (29%) or both (21%) post-SG (79%) or RYGB (21%). Technical success (successful removal of the stent) was achieved in one endoscopic session for 13 of the 14 PCSEMS (93%). One PCSEMS required the use of the stent-in-stent technique for removal. The median dwell time was 47 days (range 5-72). A distal partial occlusion developed in five patients (35%) due to tissue overgrowth and one PCSEMS (7%) migrated, necessitating premature removal. Eight patients (57%) experienced clinical success at follow-up, and six patients (43%) required subsequent treatment due to persistence or recurrence of the pathology. CONCLUSIONS: The inversion technique is a safe, effective, and efficient method of removing PCSEMS placed to correct anastomotic/staple line leaks and strictures post-SG and RYGB.

Endoscopic sleeve gastroplasty: the learning curve.

BACKGROUND AND STUDY AIMS: Endoscopic sleeve gastroplasty (ESG) is gaining traction as a minimally invasive bariatric treatment. Concern that the learning curve may be slow, even among those proficient in endoscopic suturing, is a barrier to widespread implementation of the procedure. Therefore, we aimed to define the learning curve for ESG in a single endoscopist experienced in endoscopic suturing who participated in a 1-day ESG training program. PATIENTS AND METHODS: Consecutive patients who underwent ESG between February 2016 and November 2016 were included. The performing endoscopist, who is proficient in endoscopic suturing for non-ESG procedures, participated in a 1-day ESG training session before offering ESG to patients. The outcome measurements were length of procedure (LOP) and number of plications per procedure. Nonlinear regression was used to determine the learning plateau and calculate the learning rate. RESULTS: Twenty-one consecutive patients (8 males), with mean age 47.7 ±â€Š11.2 years and mean body mass index 41.8 ±â€Š8.5 kg/m 2 underwent ESG. LOP decreased significantly across consecutive procedures, with a learning plateau at 101.5 minutes and a learning rate of 7 cases ( P  = 0.04). The number of plications per procedure also decreased significantly across consecutive procedures, with a plateau at 8 sutures and a learning rate of 9 cases ( P  < 0.001). Further, the average time per plication decreased significantly with consecutive procedures, reaching a plateau at 9 procedures ( P  < 0.001). CONCLUSIONS: Endoscopists experienced in endoscopic suturing are expected to achieve a reduction in LOP and number of plications per procedure in successive cases, with progress plateauing at 7 and 9 cases, respectively.

An Algorithmic Approach to the Management of Gastric Stenosis Following Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Gastric stenosis (GS) is a potential adverse event post-laparoscopic sleeve gastrectomy (LSG). Endoscopic management is preferred; however, there is significant variation in therapeutic strategies with no defined algorithm. This study aims to describe the safety and efficacy of a predefined step-wise algorithm for endoscopic management of GS post-LSG. METHODS: Consecutive patients with symptomatic GS post-LSG, presenting between July 2015 and August 2016, were subjected to a predefined treatment algorithm of serial dilations using achalasia balloons, followed by a fully covered self-expanding metal stent (FCSEMS) if dilations were inadequate. Patients who did not respond or opted out of ongoing endoscopic therapy were offered revision Roux-en-Y gastric bypass (RYGB). RESULTS: Total of 17 patients underwent a median of 2 (range 1-4) balloon dilations. Twelve patients (70.6%) reported clinical improvement with balloon dilation alone, while 3 (17.6%) required subsequent FCSEMS placement. One patient suffered a tear to the muscularis propria with balloon dilation, which was managed conservatively. Overall, 15 (88.2%) reported clinical improvement with endoscopic management. PAGI-SYM scores revealed that the strongest response to therapy, based on mean reduction of score ± SD, was in the following items: nausea (3 ± 1.9, P < 0.001), heartburn during day (2.8 ± 1.5, P = 0.003), heartburn on lying down (3.4 ± 1.4, P < 0.001), reflux during day (2.8 ± 1.9, P < 0.001), and reflux on lying down (3.0 ± 1.9, P < 0.001). Two (11.8%) patients failed endoscopic therapy and underwent RYGB. CONCLUSIONS: Endoscopic management of GS using the described algorithmic approach is safe and effective post-LSG. Patients with severe stenosis or helical stenosis are likely to require revision RYGB.

Greater Biosynthetic Liver Dysfunction in Primary Sclerosing Cholangitis Suggests Co-existent or Impending Cholangiocarcinoma.

Background and Aim : Patients with primary sclerosing cholangitis (PSC) who develop cholangiocarcinoma (CCA) have a median survival of less than 6 months. In half of cases, PSC and CCA will be diagnosed either concurrently or within a year of one another. The aim of the present study is to demonstrate that the degree of biochemical liver dysfunction is associated with concomitant or impending CCA. Methods : We did a chart review of patients diagnosed with PSC and CCA up to 18 months from presentation ("CCA" group) as well as patients with PSC that underwent transplantation with no sign of CCA in their explanted liver ("nCCA" group). Along with demographic data and follow-up length, we recorded their presenting liver function tests, including alanine and aspartate aminotransferases (ALT, AST), total bilirubin (TBil), alkaline phosphatase (ALP), international normalization ratio (INR), and serum Ca 19-9 levels. Differences between mean values of the two groups were analyzed with a student's t-test. Results : Twenty-four patients were included. The "CCA" group consisted of eight patients, and the "non-CCA" group had 16 patients. There was no significant difference between the two groups in their presenting values of ALT, ALP, or serum Ca 19-9. However, the "CCA" group had significantly higher levels of AST, TBil, and INR. Conclusion : Patients with PSC and concurrent or impending CCA appear to exhibit significantly greater biochemical liver dysfunction than those who do not develop CCA. Therefore, newly-diagnosed PSC patients presenting with these findings may warrant more rigorous evaluation.