Outcome of forgotten biliary stents for more than five years-A two-decade experience.

BACKGROUND AND OBJECTIVES: Prolonged biliary stenting may lead to complications such as cholangitis, stentolith and stent migration. There is limited data on forgotten biliary stents for more than five years in literature. The aim of this retrospective study was to analyze the complications and outcomes in patients who forgot to get their biliary stents removed or exchanged for more than five years. METHODS: The study population included patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) and plastic biliary stent placements in a tertiary care center from 1990 to 2022 for benign biliary diseases. Loss to follow-up and subsequent forgotten stent for more than five years were observed in 40 patients who underwent ERCP during this study period. We retrospectively analyzed the indications of stenting, present status of stent, complications and outcomes in the study patients. RESULTS: The mean age of the study patients was 51.5 ± 11.5 years with 27 females. Indications of biliary stent placement were choledocholithiasis (33, 82.5%), bile leak (3, 7.5%), benign biliary stricture (2, 5%) and choledochal cyst (2, 5%). The mean duration of forgotten stent was 5.9 ± 3.6 years. Presenting symptoms were abdominal pain (37, 92.5%), fever (26, 65%) and jaundice (32, 80%). Most commonly placed stent was 7 French double pigtail of 10 cm length. Complications in the study patients were cholangitis (35, 87.5%), internal migration (2, 5%), pancreatitis (1, 2.5%) and portal hypertension (1, 2.5%). The outcomes were stone removal (30, 90.9%), stent removal (31, 77.5%), stent reinsertion (19, 47.5%), broken stent (3, 7.5%) and surgery (2, 5%). CONCLUSIONS: Prolonged duration (> 5 years) of forgotten stent is uncommon and is observed most commonly in patients with choledocholithiasis. The most common complication of long duration of forgotten stents was cholangitis followed by internal migration, pancreatitis and portal hypertension. Stone and stent removal was successful in a majority of patents, while surgery was required in less number of patients.

Aetiology and clinical spectrum of gastric outlet obstruction in North West India.

Our study to evaluate the aetiological and clinical spectrum of gastric outlet obstruction (GOO) in North-west India showed malignant cause (54.9%) was more common than benign (45.1%). Common causes of malignancy were gall bladder (37.5%), gastric (31.8%) and pancreatic carcinoma (19.6%); commonest benign causes were opioid abuse (29%), peptic ulcer disease (21.6%), ingestion of corrosives (20.2%) and chronic pancreatitis (12.3%).

Position statement from the Indian Society of Gastroenterology, Cardiological Society of India, Indian Academy of Neurology and Vascular Society of India on gastrointestinal bleeding and endoscopic procedures in patients on antiplatelet and/or anticoagulant therapy.

Antiplatelet and/or anticoagulant agents (collectively known as antithrombotic agents) are used to reduce the risk of thromboembolic events in patients with conditions such as atrial fibrillation, acute coronary syndrome, recurrent stroke prevention, deep vein thrombosis, hypercoagulable states and endoprostheses. Antithrombotic-associated gastrointestinal (GI) bleeding is an increasing burden due to the growing population of advanced age with multiple comorbidities and the expanding indications for the use of antiplatelet agents and anticoagulants. GI bleeding in antithrombotic users is associated with an increase in short-term and long-term mortality. In addition, in recent decades, there has been an exponential increase in the use of diagnostic and therapeutic GI endoscopic procedures. Since endoscopic procedures hold an inherent risk of bleeding that depends on the type of endoscopy and patients' comorbidities, in patients already on antithrombotic therapies, the risk of procedure-related bleeding is further increased. Interrupting or modifying doses of these agents prior to any invasive procedures put these patients at increased risk of thromboembolic events. Although many international GI societies have published guidelines for the management of antithrombotic agents during an event of GI bleeding and during urgent and elective endoscopic procedures, no Indian guidelines exist that cater to Indian gastroenterologists and their patients. In this regard, the Indian Society of Gastroenterology (ISG), in association with the Cardiological Society of India (CSI), Indian Academy of Neurology (IAN) and Vascular Society of India (VSI), have developed a "Guidance Document" for the management of antithrombotic agents during an event of GI bleeding and during urgent and elective endoscopic procedures.

Indian National Association for Study of the Liver (INASL) Guidance Paper on Nomenclature, Diagnosis and Treatment of Nonalcoholic Fatty Liver Disease (NAFLD).

Nonalcoholic fatty liver disease (NAFLD) is a major cause of chronic liver disease globally and in India. The already high burden of NAFLD in India is expected to further increase in the future in parallel with the ongoing epidemics of obesity and type 2 diabetes mellitus. Given the high prevalence of NAFLD in the community, it is crucial to identify those at risk of progressive liver disease to streamline referral and guide proper management. Existing guidelines on NAFLD by various international societies fail to capture the entire landscape of NAFLD in India and are often difficult to incorporate in clinical practice due to fundamental differences in sociocultural aspects and health infrastructure available in India. A lot of progress has been made in the field of NAFLD in the 7 years since the initial position paper by the Indian National Association for the Study of Liver on NAFLD in 2015. Further, the ongoing debate on the nomenclature of NAFLD is creating undue confusion among clinical practitioners. The ensuing comprehensive review provides consensus-based, guidance statements on the nomenclature, diagnosis, and treatment of NAFLD that are practically implementable in the Indian setting.

Redefining Celiac Iceberg in Children in North India-Do Asymptomatic Subjects Need Screening?

The prevalence of celiac disease (CD) in Indian children is not well documented, with most of the studies focusing on high-risk groups and not the general population. This study was conducted to determine the prevalence of CD in asymptomatic school children of Jaipur, Rajasthan. A cross- sectional study was conducted among healthy school children of Jaipur. Demographic data, symptoms, and signs including dermatological examination were recorded. The screening for CD was done by ELISA-based anti-tissue transglutaminase (tTG) immunoglobulin A (IgA) antibody testing. Children with high IgA anti-tTG underwent upper gastrointestinal endoscopy for small bowel biopsy from the second part of the duodenum. This study involved 575 subjects, out of which, 6 (1.04%) were found to be IgA tissue transglutaminase antibody (IgA-tTG) positive. All 6 subjects were found to be having changes consistent with celiac disease on duodenal biopsy. To conclude, the calculated prevalence of celiac disease was 1 in 96 subjects.

Clinicopathological Profile and Outcome of a Large Cohort of Patients with Nonalcoholic Fatty Liver Disease from South Asia: Interim Results of the Indian Consortium on Nonalcoholic Fatty Liver Disease.

Background: Previous data from South Asia and India had shown that patients with nonalcoholic fatty liver disease (NAFLD) have mild liver disease severity. There are no data regarding long-term clinical outcomes in patients with NAFLD from South Asia. The aim of the study was to evaluate the clinicopathological profile, severity of NAFLD, and clinical outcomes in a large cohort of patients with NAFLD from South Asia. Methods: In an ongoing real-life study [Indian Consortium on nonalcoholic fatty liver disease (ICON-D)], interim data captured across 23 centers in India over 18 months was analyzed for clinicopathological profile, severity of NAFLD, and hepatic/extrahepatic events on follow-up. Results: Of 4313 patients (mean age 45 ± 12.2 years, males 52%), data on metabolic risk factors in 3553 (82.3%) patients revealed that 378 (10.6%) were lean, 575 (16.2%) overweight, 2584 (72.7%) obese; metabolic syndrome in 1518 (42.7%) and at least one metabolic risk factor in 3292 (92.6%) patients. Evidence of significant or advanced fibrosis assessed with [aspartate transaminase to platelet ratio index (APRI), n = 3196 (74%)], [fibrosis-4 (FIB-4), n = 3554 (82.4%)], [NAFLD fibrosis score (NFS), n = 1924 (44.6%)], [Fibroscan, n = 2475, (57.3%)], and histology [n = 267 (6.2%)] was present in 682 (21.3%), 676 (19%), 397 (20.6%), 715 (29%), and 41 (15.4%) patients, respectively; 246 (10%) patients on Fibroscan and 22 (8.2%) on histology had evidence of cirrhosis. On a mean follow-up 43.5 months, hepatic and extrahepatic events recorded in 1353 (31.3%) patients showed that patients with compensated cirrhosis [71 (5.2%)] had more hepatic [26 (36.7%)] and extrahepatic events [8 (11.3%)] in comparison with those without cirrhosis (P < 0.0001). Conclusion: Around one fifth of patients with NAFLD in South Asia have significant liver disease. Both hepatic and extrahepatic events on follow-up are observed more commonly in patients with nonalcoholic steatohepatitis-related compensated cirrhosis.

Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial.

BACKGROUND: The global prevalence of ulcerative colitis is increasing, and induction and maintenance of remission is a crucial therapeutic goal. We assessed the efficacy and safety of filgotinib, a once-daily, oral Janus kinase 1 preferential inhibitor, for treatment of ulcerative colitis. METHODS: This phase 2b/3, double-blind, randomised, placebo-controlled trial including two induction studies and one maintenance study was done in 341 study centres in 40 countries. Eligible patients were aged 18-75 years with moderately to severely active ulcerative colitis for at least 6 months before enrolment (induction study A: inadequate clinical response, loss of response to or intolerance to corticosteroids or immunosuppressants, naive to tumour necrosis factor [TNF] antagonists and vedolizumab [biologic-naive]; induction study B: inadequate clinical response, loss of response to or intolerance to any TNF antagonist or vedolizumab, no TNF antagonist or vedolizumab use within 8 weeks before screening [biologic-experienced]). Patients were randomly assigned 2:2:1 to receive oral filgotinib 200 mg, filgotinib 100 mg, or placebo once per day for 11 weeks. Patients who had either clinical remission or a Mayo Clinic Score response at week 10 in either induction study entered the maintenance study. Patients who received induction filgotinib were rerandomised 2:1 to continue their induction filgotinib regimen or to placebo. Patients who received induction placebo continued receiving placebo. The primary endpoint was clinical remission by Mayo endoscopic, rectal bleeding, and stool frequency subscores at weeks 10 and 58. For the induction studies, efficacy was assessed in all randomised patients who received at least one dose of study drug or placebo within that study. For the maintenance study, efficacy was assessed in all patients randomised to any filgotinib treatment group in the induction studies who received at least one dose of study drug or placebo in the maintenance study. Patients who received placebo throughout the induction and maintenance study were not included in the full analysis set for the maintenance study. Safety was assessed in all patients who received at least one dose of the study drug or placebo within each study. This trial is registered with ClinicalTrials.gov, NCT02914522. FINDINGS: Between Nov 14, 2016, and March 31, 2020, we screened 2040 patients for eligibility. 659 patients enrolled in induction study A were randomly assigned to receive filgotinib 100 mg (n=277), filgotinib 200 mg (n=245), or placebo (n=137). 689 patients enrolled into induction study B were randomly assigned to receive filgotinib 100 mg (n=285), filgotinib 200 mg (n=262), or placebo (n=142). 34 patients in induction study A and 54 patients in induction study B discontinued the study drug before week 10. After efficacy assessment at week 10, 664 patients entered the maintenance study (391 from induction study A, 273 from induction study B). 93 patients continued to receive placebo. 270 patients who had received filgotinib 100 mg in the induction study were randomly assigned to receive filgotinib 100 mg (n=179) or placebo (n=91). 301 patients who had received filgotinib 200 mg in the induction study were randomly assigned to receive filgotinib 200 mg (n=202) or placebo (n=99). 263 patients discontinued treatment in the maintenance study. At week 10, a greater proportion of patients given filgotinib 200 mg had clinical remission than those given placebo (induction study A 26·1% vs 15·3%, difference 10·8%; 95% CI 2·1-19·5, p=0·0157; induction study B 11·5% vs 4·2%, 7·2%; 1·6-12·8, p=0·0103). At week 58, 37·2% of patients given filgotinib 200 mg had clinical remission versus 11·2% in the respective placebo group (difference 26·0%, 95% CI 16·0-35·9; p<0·0001). Clinical remission was not significantly different between filgotinib 100 mg and placebo at week 10, but was significant by week 58 (23·8% vs 13·5%, 10·4%; 0·0-20·7, p=0·0420). The incidence of serious adverse events and adverse events of interest was similar between treatment groups. In the induction studies, serious adverse events occurred in 28 (5·0%) of 562 patients given filgotinib 100 mg, 22 (4·3%) of 507 patients given filgotinib 200 mg, and 13 (4·7%) of 279 patients given placebo. In the maintenance study, serious adverse events were reported in eight (4·5%) of 179 patients given filgotinib 100 mg, seven (7·7%) of 91 patients in the respective placebo group, nine (4·5%) of 202 patients in the filgotinib 200 mg group, and no patients in the respective placebo group. No deaths were reported during either induction study. Two patients died during the maintenance study; neither was related to treatment. INTERPRETATION: Filgotinib 200 mg was well tolerated, and efficacious in inducing and maintaining clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. FUNDING: Gilead Sciences.

Colitis and Crohn's Foundation (India): a first nationwide inflammatory bowel disease registry.

BACKGROUND/AIMS: The national registry for inflammatory bowel disease (IBD) was designed to study epidemiology and prescribing pattern of treatment of IBD in India. METHODS: A multicenter, cross-sectional, prospective registry was established across four geographical zones of India. Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) were enrolled between January 2014 and December 2015. Information related to demographics; disease features; complications; and treatment history were collected and analyzed. RESULTS: A total of 3,863 patients (mean age, 36.7 ± 13.6 years; 3,232 UC [83.7%] and 631 CD [16.3%]) were enrolled. The majority of patients with UC (n = 1,870, 57.9%) were from north, CD was more common in south (n = 348, 55.5%). The UC:CD ratio was 5.1:1. There was a male predominance (male:female = 1.6:1). The commonest presentation of UC was moderately severe (n = 1,939, 60%) and E2 disease (n = 1,895, 58.6%). Patients with CD most commonly presented with ileocolonic (n = 229, 36.3%) inflammatory (n = 504, 79.9%) disease. Extraintestinal manifestations were recorded among 13% and 20% of patients in UC and CD respectively. Less than 1% patients from both cohorts developed colon cancer (n = 26, 0.7%). The commonly used drugs were 5-aminosalicylates (99%) in both UC and CD followed by azathioprine (34.4%). Biologics were used in only 1.5% of patients; more commonly for UC in north and CD in south. CONCLUSIONS: The national IBD registry brings out diversities in the 4 geographical zones of India. This will help in aiding research on IBD and improving quality of patient care.

Celiac Disease and Portal Hypertension: A Causal Association or Just a Coincidence?

INTRODUCTION: Celiac disease (CD) has been linked to portal hypertension (PHT) of varied etiology, but the causality association has never been proved. We aim to study the prevalence of CD in patients of PHT of different etiology. METHODS: A prospective observational study was conducted from June 2017 to December 2018 involving all the cases of PHT of varied etiology. Consecutive patients of PHT with chronic liver disease (CLD) of defined etiology like ethanol, viral hepatitis (B or C), Budd-Chiari syndrome (BCS), autoimmune-related cirrhosis, and cryptogenic CLD (cCLD) (group A) and those with noncirrhotic PHT (NCPHT), which included noncirrhotic portal fibrosis (NCPF) and extrahepatic portal vein obstruction (EHPVO) (group B), were screened for CD by IgA anti-tTG antibody followed by duodenal biopsy in serology-positive patients. RESULTS: Out of a total of 464 patients, group A constituted 382 patients, CLD related to ethanol (155), cCLD (147), hepatitis B (42), hepatitis C (21), autoimmune (10), and BCS (7), whereas 82 patients were in group B with NCPF (64) and EHPVO (18). Total 29 patients were diagnosed with CD in both groups, 17 in group A (4.5%) and 12 in group B (14.6%). In group A, 13 patients with cCLD, two with HBV-related CLD, one with BCS, and one with autoimmune-related CLD were concomitantly diagnosed as CD. In group B, CD was diagnosed in 12 patients of NCPF (11) and EHPVO (1). Liver histology showed chronic hepatitis in two patients and was normal in three patients. CONCLUSION: CD is common in PHT of different etiology, especially in cCLD, NCPH and autoimmune hepatitis; however, the etiological basis for this association is still to be defined. The likelihood of CD is higher in liver disease than the general population, and these patients should be screened for CD.

Diet and inflammatory bowel disease: The Asian Working Group guidelines.

INTRODUCTION: These Asian Working Group guidelines on diet in inflammatory bowel disease (IBD) present a multidisciplinary focus on clinical nutrition in IBD in Asian countries. METHODOLOGY: The guidelines are based on evidence from existing published literature; however, if objective data were lacking or inconclusive, expert opinion was considered. The conclusions and 38 recommendations have been subject to full peer review and a Delphi process in which uniformly positive responses (agree or strongly agree) were required. RESULTS: Diet has an important role in IBD pathogenesis, and an increase in the incidence of IBD in Asian countries has paralleled changes in the dietary patterns. The present consensus endeavors to address the following topics in relation to IBD: (i) role of diet in the pathogenesis; (ii) diet as a therapy; (iii) malnutrition and nutritional assessment of the patients; (iv) dietary recommendations; (v) nutritional rehabilitation; and (vi) nutrition in special situations like surgery, pregnancy, and lactation. CONCLUSIONS: Available objective data to guide nutritional support and primary nutritional therapy in IBD are presented as 38 recommendations.

Endoscopic ultrasound-guided thrombin injection for management of visceral artery pseudoaneurysm: A novel approach.

Visceral artery pseudoaneurysm is a rare and potentially life-threatening vascular entity with a high mortality rate, conventionally managed with digital subtraction angiography with coil embolization or surgery. However, in cases where angiographic coil embolization is not possible due to technical reasons, computerized tomography (CT)/ultrasonography-guided thrombin injection remains a viable option as described in the literature. In this case series, we intend to highlight the role of endoscopic ultrasound-guided thrombin injection in the management of abdominal visceral artery pseudoaneurysm, which is either inaccessible by endovascular route or have high surgical risk of complication.

Comparative study of tinidazole versus metronidazole in treatment of amebic liver abscess: A randomized control trial.

BACKGROUND: Metronidazole is a drug of choice for amebic liver abscess (ALA), but has long course and significant side effects. Thus, drugs like tinidazole with a better tolerability record need evaluation. METHODS: We conducted a randomized controlled trial at the Department of Gastroenterology, SMS Hospital, Jaipur, India. One hundred and fifty admitted patients were randomized into two treatment groups, metronidazole (group M, n = 75) and tinidazole (group T, n = 75). Patients were observed for clinical response, laboratory parameters, imaging, and side effects. Early clinical response (ECR) was defined as the absence of fever and abdominal pain within 72 h of treatment. Symptomatic clinical response (SCR) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required. Follow up was done at 1, 3, and 6 months. RESULTS: ECR was 62.3% in group T vs. 37.7% in group M (p = 0.02). SCR was shorter in group T than group M (3.29 ± 1.61 days vs. 5.67 ± 2.93, p ≤ 0.001). Mean residual volume at the end of 1 month was lower in group T (130.7 ± 108.1 vs. 184.7 ± 143.3 mL, p = 0.01) and no significant difference was seen at 3 and 6 months. Tinidazole was better tolerated with fewer side effects. Low socioeconomic status, baseline abscess volume > 500 mL, hypoalbuminemia, pleural effusion, and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor. CONCLUSION: Tinidazole, as compared to metronidazole, has early clinical response, shorter treatment course, favorable rate of recovery, and high tolerability; thus, tinidazole can be preferred over metronidazole in ALA.

INASL Position Statements on Prevention, Diagnosis and Management of Hepatitis B Virus Infection in India: The Andaman Statements.

Hepatitis B Virus (HBV) infection is one of the major causes of morbidity, mortality and healthcare expenditure in India. There are no Indian consensus guidelines on prevention, diagnosis and management of HBV infection. The Indian National Association for Study of the Liver (INASL) set up a taskforce on HBV in 2016, with a mandate to develop consensus guidelines for diagnosis and management of HBV infection, relevant to disease patterns and clinical practices in India. The taskforce first identified contentious issues on various aspects of HBV management, which were allotted to individual members of the taskforce who reviewed them in detail. A 2-day round table discussion was held on 11th and 12th February 2017 at Port Blair, Andaman & Nicobar Islands, to discuss, debate, and finalize the consensus statements. The members of the taskforce reviewed and discussed the existing literature threadbare at this meeting and formulated the 'INASL position statements' on each of the issues. The evidence and recommendations in these guidelines have been graded according to the Grading of Recommendations Assessment Development and Evaluation (GRADE) system with minor modifications. The strength of recommendations (strong: 1, weak: 2) thus reflects the quality (grade) of underlying evidence (A, B, C, D). We present here the INASL position statements on prevention, diagnosis and management of HBV in India.

Efficacy and Safety of Direct Acting Antiviral Therapy for Chronic Hepatitis C in Thalassemic Children.

OBJECTIVES: There is limited data on the efficacy and safety of directly acting antiviral therapy (DAA) for chronic hepatitis C in pediatric population. The aim was to assess the efficacy and safety of DAA in chronic hepatitis C ß-thalassemic major pediatric patients. METHODS: Prospective study was conducted from September 2015 to January 2017. All ß-thalassemic major chronic hepatitis C pediatric patients with age between 5 and 14 years were included in this study. Data related to demography, laboratory parameters, hepatitis C viral load, genotype and outcome of antiviral therapy was analyzed. DAA was planned according to EASL guidelines 2015 for chronic hepatitis C therapy in adults. OBSERVATIONS: Fourteen ß-thalassemic major patients (median age was 9.5 y, 12 male) were studied. All patients were of genotype 3, received DAA (sofosbuvir 400 mg+daclatasvir 80 mg) for 12 weeks. The median viral load was 2.5×10 IU/mL. End of treatment response and sustained virological response at 12 weeks was achieved in all the patients. Serum alanine aminotransferase, aspartate aminotransferase, ferritin, and albumin significantly reduced after DAA. CONCLUSIONS: DAA in adult dosage are safe and effective for treatment of chronic hepatitis C (genotype 3) in pediatric ß-thalassemic major population.

A prospective study to evaluate the role of duodenal bulb biopsy in the diagnosis of celiac disease.

BACKGROUND: Celiac disease (CeD) requires a biopsy from the small intestine to confirm the diagnosis. Conventionally, duodenal bulb (D1) was avoided as a biopsy site due to histological confounding factors at this site. However, sometimes, the bulb mucosa is the only affected site. The aim of the present study was to assess changes in duodenal bulb histology and compare it to distal duodenal histology and to analyze whether the addition of duodenal bulb biopsy increases the diagnostic yield of the CeD. METHODS: It was a prospective study comprising of 98 patients of CeD who were symptomatic clinically and had positive anti tissue transglutaminase (tTG) antibody. Endoscopically four mucosal biopsies were taken, two each from the bulb and distal duodenum, and morphology was graded as per modified Marsh grade. RESULTS: Iron deficiency anemia (40%) was a most common clinical presentation followed by chronic diarrhea (30%). Sixty patients showed same Marsh grade and 38 showed different Marsh grade at both sites. Patients who were showing the difference in the Marsh grade at the two biopsy sites, in place of; descending duodenum showed higher grade in 24 patients while higher mucosal atrophy was documented in the bulb in 14 patients. No patient of CeD had isolated D1 involvement. In eight patients, the correct diagnosis of CeD could be made only because of bulb biopsy. CONCLUSION: Majority of the patients had no classical symptoms. Different Marsh grade at the two biopsy sites was documented demonstrating the patchy distribution of CeD. Combining biopsy from both bulb and descending duodenum maximizes the diagnostic yield of the CeD.

Imaging of the small intestine in Crohn's disease: Joint position statement of the Indian Society of Gastroenterology and Indian Radiological and Imaging Association.

The Indian Society of Gastroenterology (ISG) Task Force on Inflammatory Bowel Disease and the Indian Radiological and Imaging Association (IRIA) developed combined ISG-IRIA evidence-based best-practice guidelines for imaging of the small intestine in patients with suspected or known Crohn's disease. These 29 position statements, developed through a modified Delphi process, are intended to serve as reference for teaching, clinical practice, and research.

Endoscopic management of pancreatic pseudocysts and walled-off pancreatic necrosis: A two-decade experience.

AIM: To determine long-term outcome of endoscopic management of pancreatic pseudocyst/walled-off pancreatic necrosis (WOPN) without necrosectomy. METHODS: One-hundred and sixty-five pancreatic pseudocysts/WOPN managed endoscopically over a period of 22 years were analyzed retrospectively for technical success, complications, and recurrence. RESULTS: Symptomatic 118 males and 47 females with mean age of 35.8 years were included. Alcohol was the most common etiology (41.2%). Transmural endoscopic drainage was done in 144 patients, while 21 patients underwent transpapillary drainage. All the patients were subjected to contrast computed tomography (CT) abdomen or routine/Doppler ultrasound. Endoscopic ultrasound was done in last 11 patients. One or two double pigtail 7 Fr stents were placed when clear watery fluid came out from cyst (130 patients, 78.8%), and nasocystic drainage (NCD) tubes were placed in addition to two 7 Fr stents when there were frank pus, thick dark fluid, or solid components inside the cyst (35 patients). All these patients settled on this treatment. Thirty-three of 35 patients of WOPN could be managed endoscopically without necrosectomy. Complications occurred in 9.2% of pseudocysts and 40% of WOPN. Thirty-five patients were followed up for more than 5 years (3 patients more than 10 years), and 130 patients were followed up for up to 5 years. Recurrence occurred in 8.1% of pseudocysts and 5.7% of WOPN. CONCLUSION: Majority of pancreatic pseudocysts/WOPN can be managed with endoscopic drainage without necrosectomy with high success, low complication, and recurrence rates.

Comparative evaluation of magnetic resonance cholangiopancreatography/magnetic resonance splenoportovenography and endoscopic ultrasound in the diagnosis of portal cavernoma cholangiopathy.

BACKGROUND: Magnetic resonance cholangiopancreatography/magnetic resonance splenoportovenography (MRCP/MRSPV) is now the investigation of choice for the diagnosis of portal cavernoma cholangiopathy (PCC). Endoscopic ultrasound (EUS) is an emerging diagnostic modality for the diagnosis of PCC and may be better than MRCP/MRSPV to see the layer-wise localization of varices and to differentiate between varices, stone, and malignancy. METHODS: Retrospective data of 50 patients of extrahepatic portal vein obstruction (EHPVO) were collected, and comparison between MRCP/MRSPV and EUS was done for the diagnosis of PCC. RESULTS: Out of 50 patients, 56 % (28) were males, 44 % (22) females, and 24 % (12) symptomatic. Biliary changes were seen in 40 patients (80 %). Epicholedochal collateral (EPEC) was detected in 48 % and 20 % in MRCP/MRSPV and EUS, respectively. Perforators (PER) and intracholedochal collateral (ICC) were better seen with EUS (72 % and 48 %) as compared to MRCP/MRSPV (0 % and 8 %), and p-values were significant (<0.05). EUS has a sensitivity of 33.33 % and a specificity of 92.31 % for EPEC. Portal cavernoma (PC) and collateral at porta (CP), paracholedochal collateral (PAC), perisplenic (PS) and peripancreatic collateral (PPC), pericholedochal collateral (PEC), intrahepatic biliary radical dilatation (IHBRD), perigallbladder collateral (PG), common bile duct dilatation (CBDD) and common hepatic duct dilatation (CHDD), common bile duct stricture (CBDS), and retropancreatic collateral (RPC) were comparable between the two modalities. CONCLUSIONS: EUS detected PER and ICC better than MRCP/MRSPV, while MRCP/MRSPV was more sensitive for detecting EPEC.

A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED).

OBJECTIVES: In the largest head-to-head comparison between an oral and an intravenous (IV) iron compound in patients with inflammatory bowel disease (IBD) so far, we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia (IDA). METHODS: This prospective, randomized, comparative, open-label, non-inferiority study was conducted at 36 sites in Europe and India. Patients with known intolerance to oral iron were excluded. A total of 338 IBD patients in clinical remission or with mild disease, a hemoglobin (Hb) <12 g/dl, and a transferrin saturation (TSAT) <20% were randomized 2:1 to receive either IV iron isomaltoside 1,000 according to the Ganzoni formula (225 patients) or oral iron sulfate 200 mg daily (equivalent to 200 mg elemental iron; 113 patients). An interactive web response system method was used to randomize the eligible patient to the treatment groups. The primary end point was change in Hb from baseline to week 8. Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of -0.5 g/dl. The secondary end points, which tested for superiority, included change in Hb from baseline to weeks 2 and 4, change in s-ferritin, and TSAT to week 8, number of patients who discontinued study because of lack of response or intolerance of investigational drugs, change in total quality of life (QoL) score to weeks 4 and 8, and safety. Exploratory analyses included a responder analysis (proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks), the effect of regional differences and total iron dose level, and other potential predictors of the treatment response. RESULTS: Non-inferiority in change of Hb to week 8 could not be demonstrated. There was a trend for oral iron sulfate being more effective in increasing Hb than iron isomaltoside 1,000. The estimated treatment effect was -0.37 (95% confidence interval (CI): -0.80, 0.06) with P=0.09 in the full analysis set (N=327) and -0.45 (95% CI: -0.88, -0.03) with P=0.04 in the per protocol analysis set (N=299). In patients treated with IV iron isomaltoside 1,000, the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 (95% CI: 18.6, 78.8) with P=0.002, whereas the mean change in TSAT was lower with an estimated treatment effect of -4.4 (95% CI: -7.4, -1.4) with P=0.005, compared with patients treated with oral iron. No differences in changes of QoL were observed. The safety profile was similar between the groups. The proportion of responders with Hb ≥2 g/dl (IV group: 67%; oral group: 61%) were comparable between the groups (P=0.32). Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of >1,000 mg IV. Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein (CRP). CONCLUSIONS: We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study. Based on the dose-response relationship observed with the IV iron compound, we suggest that the true iron demand of IV iron was underestimated by the Ganzoni formula in our study. Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD.