Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series.

Medical burden of fatal adverse drug reactions (FADRs) is significant. The epidemiological data on FADR do exist from the western world, but there is scanty from India. We hereby report a case series of FADRs recorded in a 2 years period. Point prevalence of FADRs was 0.223%. Point prevalence of all cause death in the hospital was 1.20%. The drugs causing FADRs were injection bupivacaine, amphotericin B, directly observed treatment short-course Category-1, injection streptokinase, and tablet ferrous sulfate. All these FADR were labeled as possible expect one case as probable. All FADR were labeled as type A. In three out of five the central nervous system was involved, while the hepatic system and multiorgan failure accounted for one case each. Two cases each were acute and subacute, while one was latent in nature. Reporting of FADRs shall go a long way in patient safety.

Clinical profile of calcific and noncalcific chronic pancreatitis in north India.

GOALS: To compare the clinical profile of calcific and noncalcific chronic pancreatitis (CP) in north India. BACKGROUND: The profile of calcific CP has not been adequately studied. STUDY: Detailed demographic data were recorded; hematologic, biochemical, and radiologic investigations were carried out on 225 patients with CP. The patients were divided into calcific and noncalcific groups based on the presence of pancreatic calcification, which was detected on computed tomography. RESULTS: Calcific CP was reported in 46.7% of the patients and noncalcific CP in 53.3%. The mean age, duration of symptoms before presentation, sex ratio, body mass index, and frequency of various symptoms and complications including abdominal pain, ascites, pleural effusion, and segmental portal hypertension was not statistically different between the 2 groups. However, pseudocysts occurred more frequently in noncalcific CP, whereas jaundice because of bile duct stricture, diabetes mellitus, and steatorrhea occurred more frequently in patients with calcific CP (P<0.05). On comparing calcific and noncalcific alcoholic pancreatitis, only steatorrhea was reported more frequently in patients with calcific alcoholic CP. However, pseudocysts and segmental portal hypertension occurred more frequently in noncalcific idiopathic CP, whereas diabetes mellitus occurred more frequently in patients with calcific idiopathic CP (P<0.05). On comparing calcific alcoholic CP with calcific idiopathic CP, we found significantly lower mean age in patients with idiopathic CP and a higher frequency of male patients and pseudocysts in alcoholic CP (P<0.05). CONCLUSION: Calcific CP has a higher frequency of bile duct stricture, diabetes mellitus, and steatorrhea, whereas noncalcific CP has higher frequency of pseudocysts and segmental portal hypertension.

Endoscopic balloon dilatation without fluoroscopy for treating gastric outlet obstruction because of benign etiologies.

BACKGROUND: Benign gastric outlet obstruction (GOO) causes considerable morbidity and conventional treatment has been surgery. Endoscopic balloon dilatation is a minimally invasive treatment modality for GOO but experience with its use is mainly in patients with GOO due to peptic ulcer disease. We report our experience of endoscopic balloon dilatation in benign GOO of various etiologies. METHODS: Over 4 years, 25 patients with benign GOO were treated by endoscopic balloon dilatation done with through-the-scope controlled radial expansion (CRE) balloon dilators. Dilatation was repeated every 2 weeks with the end point being dilation of 15 mm or the need for surgery. Helicobacter pylori, when present, was eradicated. RESULTS: Etiology of benign GOO was peptic ulcer (11), corrosive ingestion (7), chronic pancreatitis (4, groove pancreatitis in 1), tuberculosis (2), and Crohn's disease (1). Endoscopic balloon dilatation was successful in 21/25 (84%) patients. Patients required one to six sessions of endoscopic dilatation (mean=2.2±1.2). Corrosive-induced GOO required more dilatation sessions (3.83±0.75) compared to peptic GOO (2.1±0.56; p<0.05). Balloon dilatation was also effective in patients with GOO due to gastroduodenal tuberculosis and Crohn's disease. Patients with chronic pancreatitis-related GOO had poor response to dilatation, with two patients (50%) requiring surgery and the remaining two with recurrence of symptoms requiring repeat dilatation. None of the other patients with successful treatment had recurrence of symptoms. Complication in the form of perforation was noted in two patients (8%). CONCLUSIONS: Endoscopic balloon dilatation is an effective, safe, and minimally invasive treatment modality for benign gastric outlet obstruction.

Endoscopic management of pancreatic pseudocysts at atypical locations.

BACKGROUND AND AIMS: There is paucity of data on endoscopic management of pseudocysts at atypical locations. We evaluated the efficacy of endoscopic transpapillary nasopancreatic drain (NPD) placement in the management of pseudocysts of pancreas at atypical locations. PATIENTS AND METHODS: Eleven patients with pseudocysts at atypical locations were treated with attempted endoscopic transpapillary nasopancreatic drainage. On endoscopic retrograde pancreatography (ERP), a 5-F NPD was placed across/near the site of duct disruption. RESULTS: Three patients each had mediastinal, intrahepatic, and intra/perisplenic pseudocysts and one patient each had renal and pelvic pseudocyst. Nine patients had chronic pancreatitis whereas two patients had acute pancreatitis. The size of the pseudocysts ranged from 2 to 15 cm. On ERP, the site of ductal disruption was in the body of pancreas in five patients (45.4%), and tail of pancreas in six patients (54.6%). All the patients had partial disruption of pancreatic duct. The NPD was successfully placed across the disruption in 10 of the 11 patients (90.9%) and pseudocysts resolved in 4-8 weeks. One of the patients developed fever, 5 days after the procedure, which was successfully treated by intravenous antibiotics. In another patient, NPD became blocked 12 days after the procedure and was successfully opened by aspiration. The NPD slipped out in one of the patient with splenic pseudocyst and was replaced with a stent. There was no recurrence of symptoms or pseudocysts during follow-up of 3-70 months. CONCLUSION: Pancreatic pseudocysts at atypical locations with ductal communication and partial ductal disruption that is bridged by NPD can also be effectively treated with endoscopic transpapillary NPD placement.

Etiological and Endoscopic Profile of Middle Aged and Elderly Patients with Upper Gastrointestinal Bleeding in a Tertiary Care Hospital in North India: A Retrospective Analysis.

BACKGROUND: Upper gastrointestinal (GI) bleeding is a common medical emergency associated with significant morbidity and mortality. The clinical presentation depends on the amount and location of hemorrhage and the endoscopic profile varies according to different etiology. At present, there are limited epidemiological data on upper GI bleed and associated mortality from India, especially in the middle and elderly age group, which has a higher incidence and mortality from this disease. AIM: This study aims to study the clinical and endoscopic profile of middle aged and elderly patients suffering from upper GI bleed to know the etiology of the disease and outcome of the intervention. MATERIALS AND METHODS: Out of a total of 1790 patients who presented to the hospital from May 2015 to August 2017 with upper GI bleed, and underwent upper GI endoscopy, data of 1270 patients, aged 40 years and above, was compiled and analyzed retrospectively. RESULTS: All the patients included in the study were above 40 years of age. Majority of the patients were males, with a male to female ratio of 1.6:1. The most common causes of upper GI bleed in these patients were portal hypertension-related (esophageal, gastric and duodenal varices, portal hypertensive gastropathy, and gastric antral vascular ectasia GAVE), seen in 53.62% of patients, followed by peptic ulcer disease (gastric and duodenal ulcers) seen in 17.56% of patients. Gastric erosions/gastritis accounted for 15.20%, and duodenal erosions were seen in 5.8% of upper GI bleeds. The in-hospital mortality rate in our study population was 5.83%. CONCLUSION: The present study reported portal hypertension as the most common cause of upper GI bleeding, while the most common endoscopic lesions reported were esophageal varices, followed by gastric erosion/gastritis, and duodenal ulcer.

Endoscopic examination of the upper esophagus by withdrawal of endoscope over guide wire.

Upper gastrointestinal (UGI) endoscopy is an important diagnostic modality in evaluation of patients with upper gastrointestinal (GI) disorders. However, lesions located in the cricopharyngeal area and upper esophagus can be missed, as this area may not be well visualized during endoscopy. This study was conducted to study the utility of a new technique of endoscopic examination of the upper esophagus by withdrawal of endoscope over guide wire in diagnosing esophageal disorders. Patients with suspected upper esophageal disorders on history and radiological investigations were assessed using guide wire assisted endoscopic examination during withdrawal of the endoscope. In this technique, endoscope is inserted into the esophagus under vision and thereafter the whole of esophagus, stomach and proximal duodenum is examined. The endoscope is then withdrawn into the mid-esophagus, a guide wire is fed into the biopsy channel, and thereafter inserted into the esophagus. Once guide wire has been advanced into the esophagus, the endoscope is withdrawn gently over the guide wire into esophagus carefully examining for lesions in upper esophagus and cricopharyngeal area. Twenty cases of various abnormalities localized to the upper esophagus were studied. The final diagnosis in these patients was cervical esophageal web (10), post transhiatal esophagectomy leak (4), heterotopic gastric mucosa (3), posttraumatic esophageal perforation (2), and Zenker's diverticulum (1). Intact web was detected in 2 patients and in 8 patients fractured web was seen. Guide wire assisted examination of upper esophagus improved the ability to visualize and characterize these lesions and no complications were encountered as a result of this procedure. Endoscopic examination of the upper esophagus by withdrawal of endoscope over guide wire is safe and effective in diagnosing anatomical abnormalities of the upper esophagus that may be missed or poorly characterized during standard endoscopy.

Successful resolution of a mediastinal pseudocyst and pancreatic pleural effusion by endoscopic nasopancreatic drainage.

CONTEXT: A mediastinal pseudocyst is an unusual complication of acute and chronic pancreatitis. The ideal form of management is controversial, and various successful therapeutic interventions including surgical resection, internal or external drainage, and non-operative radiological drainage techniques have been described. Successful resolution of a mediastinal pseudocyst with endoscopic transpapillary stent placement has been described in fewer than five cases. CASE REPORT: We report a case of chronic pancreatitis with complete pancreas divisum together with a mediastinal pseudocyst and pancreatic pleural effusion in which magnetic resonance imaging and endoscopic retrograde pancreatography demonstrated communication of the abdominal pseudocyst with the posterior mediastinum through the diaphragmatic hiatus. This case was successfully treated with endoscopic transpapillary nasopancreatic drain placement alone. CONCLUSION: A communicating mediastinal pseudocyst can be successfully treated by endoscopic transpapillary nasopancreatic drainage alone.

An intra-hepatic pancreatic pseudocyst successfully treated endoscopic transpapillary drainage alone.

CONTEXT: An intra-hepatic pseudocyst is a very rare complication of acute and chronic pancreatitis with less than thirty cases described in the literature. Successful resolution of intra-hepatic pseudocysts with endoscopic transpapillary nasopancreatic drain placement has not previously been described. CASE REPORT: We report the case of a 34-year-old male with chronic idiopathic non-calcific pancreatitis, anomalous pancreatobiliary junction and a large intra-hepatic pancreatic pseudocyst along with a large abdominal pseudocyst who was successfully treated by endoscopic transpapillary nasopancreatic drainage alone. CONCLUSION: Pancreatic pseudocysts can present as intra-hepatic cystic lesions and communicating intra-hepatic pseudocysts can be successfully treated by endoscopic transpapillary nasopancreatic drainage alone.

Gastrointestinal bleed induced by a fixed dose combination of rabeprazole and diclofenac sodium.

Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastrointestinal (GI) bleed. Co-administration of proton pump inhibitors (PPIs) has been widely suggested as one of the strategies to prevent these GI complications among NSAIDs users. Herein, we present a case of severe GI bleeding in a patient taking fixed dose combination (FDC) of rabeprazole (20 mg) and diclofenac sodium (100 SR).

Comparative evaluation of transpapillary drainage with nasopancreatic drain and stent in patients with large pseudocysts located near tail of pancreas.

BACKGROUND: Endoscopic transpapillary drainage is usually not advocated for large pseudocysts for fear of infection. We compared efficacy of transpapillary drainage with nasopancreatic drain (NPD) or stent alone in large pseudocysts (>6 cm) located near tail of pancreas. METHODS: In a prospective study, a 5-Fr stent/NPD was placed across/near pancreatic duct disruption in 11 patients (nine chronic and two acute pancreatitis) with large pseudocysts located near tail of pancreas. The patients were followed up for resolution of pseudocyst, need for surgery, and complications. RESULTS: Pseudocysts diameter ranged from 7 to 15 cm. An attempt to place NPD was made in five patients and a stent in six patients. In NPD group, deep cannulation could not be achieved in one patient; it was treated successfully with percutaneous drainage. In four patients with partial duct disruption, NPD was successfully placed bridging disruption and all had resolution within 6 weeks. In stent group, five had partial and one had complete duct disruption, who later recovered by placement of a stent. Of five patients with partial disruption, one recovered uneventfully at 6 weeks with stent bridging disruption. Other four patients (bridging stent in three) developed febrile illness and infection of pseudocyst. They required additional percutaneous drainage and antibiotics. There was no recurrence of pseudocysts over follow-up of 16.4 months. CONCLUSION: Endoscopic transpapillary drainage with NPD bridging disruption is associated with good outcome in patients with large pseudocysts at tail end of pancreas. However, there was increased frequency of infection when stent was used for drainage.