Prevalence of gallstone disease in patients with type 2 diabetes and the risk factors in North Indian population: a case control study.

BACKGROUND: Age, female sex, and obesity are considered to be risk factors for gallstone disease. The role of type 2 diabetes (T2D) in gallstone formation is still uncertain, and data in Indians is limited. OBJECTIVES: This is a case-control study to determine the prevalence of gallstones (GS) in patients with T2D, risk factors, and the relative risk compared with subjects without diabetes, selected from the general population. METHODS: Among 450 cases with T2D of a ≥2-year duration, 377 (88.8 %) participated. Diagnosis of GS was made at ultrasonography and history of cholecystectomy for GS. Controls were selected from the general population and diabetes excluded by oral glucose tolerance test. Cases and controls were matched for age, gender, and body mass index (BMI). RESULTS: Gallstones were seen in 67 (17.7 %) cases compared to 40 (5.8 %) in controls (p = 0.001). Prevalence increased with increasing age with peak in the sixth decade (23.4 % in cases and 4.4 % in controls (p = 0.001) and was higher in women (27.9 %) in cases and (7.8 %) in controls, (p = 0.001). In univariate analysis, risk factors for GS included age, female sex, BMI, multiparity, family history of GS, and high triglycerides and cholesterol with low high-density lipoprotein cholesterol. In multivariate analysis, age, (relative risk [RR] 1.54, confidence interval [CI] 1.1-2.1), female sex (RR 1.6, CI 1.0-1.9), and BMI (RR 1.5, CI 1.3-2.5) were the independent risk factors in gallstone formation. CONCLUSION: Patients with T2D had higher probability of having GS compared to the general population. Increasing age, female sex, and higher BMI were independently associated with gallstone disease.

Efficacy and safety of sequential therapy versus standard triple therapy in Helicobacter pylori eradication in Kashmir India: a randomized comparative trial.

BACKGROUND: Increasing resistance against Helicobacter pylori has resulted in reduced eradication rates. OBJECTIVE: This study aims to determine whether eradication rates for H. pylori infection with sequential therapy is better than standard triple therapy. PATIENTS: Patients with endoscopy documented peptic ulcer and H. pylori infection confirmed by histology and rapid urease test. INTERVENTION: Patients were randomized into two groups; 134 received standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg and amoxicillin 1 g each administered twice daily) for 10 days and 138 received sequential regimen (pantoprazole 40 mg plus amoxicillin 1 g twice daily for 5 days followed by 40 mg pantoprazole, 500 mg clarithromycin, and 500 mg tinidazole each administered twice daily for 5 days). Eradication was confirmed by histology and rapid urease test. Compliance and adverse effects were determined by the recovery of empty medicine strips and questioning. RESULTS: The eradication rates with sequential therapy were significantly greater than with standard therapy on both intention-to-treat analysis (76.0 % vs. 61.9 %, p = 0.005; difference, 14.1 % [95 % CI, 6.5-19 %] and per protocol analysis (84.6 % vs. 67.4 %, p = 0.002; difference, 17.2 % [95 % CI, 8.5-23.5 %]). The incidence of side effects did not differ between the two therapy groups. One patient in standard therapy discontinued treatment due to side effects. LIMITATION: Cultures were not performed. Loss to follow up was 5.2 % in standard therapy and 6.5 % in sequential therapy. CONCLUSION: Sequential therapy was significantly more effective than standard therapy for eradicating H. pylori infection in peptic ulcer disease in Asian patients. Side effects were similar.

Prevalence of Helicobacter pylori infection and the effect of its eradication on symptoms of functional dyspepsia in Kashmir, India.

BACKGROUND AND AIM: Epidemiology of Helicobacter pylori infection has regional variation. Effect of eradication of H. pylori on symptoms of functional dyspepsia is uncertain, and the data in Asian scenario are scanty. The study aimed to see H. pylori positivity rate in patients of functional dyspepsia and the effect of its eradication on symptoms. METHODS: Randomized, double-blind, placebo-controlled study was the study design used. Patients of functional dyspepsia defined as per Rome 2 criteria were tested for H. pylori infection by rapid urease test and gastric biopsy. H. pylori-positive patients were randomly allocated to triple therapy (20 mg of omeprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin orally two times daily) and omeperazole plus identical placebo for 2 weeks. Symptoms were assessed with the weekly Likert scale. RESULTS: H. pylori positivity rate in functional dyspepsia was 1160/2000 (58%). At 6 weeks, the eradication rate for H. pylori in triple therapy and placebo group was (181/259 [69.8%] and 13/260 [5.0%], P = 0.001), respectively. On intention-to-treat analysis, the symptom resolution at 1 month was (157/259 [60.7%] and 136/260 [52.3%], P = 0.38), respectively. At 12 months, H. pylori eradication and healing of gastritis in triple therapy and placebo group were (116/174 [66.7%] and 12/180 [6.7%], P = 0.001) and (132/174 [75.9%] and 11/180 [6.1%], P = 0.001), respectively. On intension to treat, the resolution of symptoms in triple therapy and placebo group was (95/217 [43.7%] and 72/195 [36.9%], P = 0.13). CONCLUSION: There is high H. pylori positivity rate in patients of functional dyspepsia. The eradication of H. pylori does not resolve the symptoms despite healing of gastritis.

Safety and efficacy of 1-week levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori-related peptic ulcer disease in Kashmir, India.

BACKGROUND AND OBJECTIVES: There is no ideal therapy for eradication of Helicobacter pylori infection. We evaluated the efficacy and safety of 1-week triple therapy with rabeprazole, levofloxacin, and tinidazole in a metronidazole resistance prevalent region for eradicating H. pylori infection in patients with gastroduodenal ulcers. METHODS: This was an open-label, prospective study. Consecutive patients with endoscopy-proven duodenal or gastric ulcer and who were H. pylori-positive were treated with levofloxacin 500 mg once a day, rabeprazole 20 mg twice a day, and tinidazole 500 mg twice daily for 7 days followed by rabeprazole 20 mg OD for 8 weeks. Endoscopy was repeated 8 weeks after the end of therapy to check for ulcer healing and H. pylori status. RESULTS: One hundred and thirty-one patients with gastroduodenal ulcers (duodenal 118, and gastric 13) were included. Drug compliance was 97.7 %. The eradication rate of H. pylori by intention-to-treat analysis was 85.5 % (95 % confidence interval 79.5-91.5) (112 of 131 patients) and by per-protocol analysis was 91.8 % (95 % confidence interval 86.9-96.7) (112 of 122 patients). Adverse effects were reported in 17 %: abdominal pain in 3.05 %, metallic taste in 6.87 %, and nausea and vomiting in 4.58 %. CONCLUSIONS: Levofloxacin-tinidazole-based triple therapy was highly effective and safe as a first-line regimen in Indian patients with gastroduodenal ulcer disease associated with H. pylori infection. The regimen was well tolerated.

64-section multiphase CT enterography as a diagnostic tool in the evaluation of obscure gastrointestinal bleeding.

BACKGROUND AND AIM: Small bowel follow through (SBFT) and enteroclysis have low sensitivity in picking up lesions in obscure gastrointestinal bleed (OGIB). Computed tomographic enterography (CT-EG), performed with 64-slice multiphase CT system by using large volumes of ingested neutral enteric contrast material, has high spatial and temporal resolution in visualization of the small bowel wall and lumen. The role of 64-slice multiphase CT-EG in the evaluation of OGIB is still evolving, and data on this role are scarce. We evaluated the efficacy of 64-slice multiphase CT-EG using polyethylene glycol (PEG) electrolyte solution as neutral contrast in patients of OGIB. METHODS: CT-EG was performed with 64-slice multiphase CT system using large volume (2,000 mL) of PEG electrolyte solution as oral contrast in patients of OGIB. RESULTS: Thirty-five patients (21 men, age 41.4 [13.5] y, range 19-70 year) with OGIB underwent CT-EG; 20 patients had overt OGIB whereas 15 patients had occult OGIB. Among 15 patients with occult OGIB, 10 patients had iron deficiency anemia (IDA) with fecal occult blood test (FOBT) positive and 5 had IDA with FOBT negative. Thirty-two patients (92 %) completed the procedure successfully. The total time taken for the ingestion of 2,000 mL of PEG electrolyte solution was median 64 (range 60-78) minutes. Adequate luminal distension of small bowel was seen in 29 (90.6 %) patients for successful interpretation of radiological images. Fifteen of 32 (46.9 %) patients had positive findings on CT-EG; 12 of them underwent exploratory laparotomy. The surgical findings were in conformity with CT-EG findings in all patients, which included gastrointestinal stromal tumors (GIST; n = 6), carcinoid (1), Meckel's diverticulum (1), small bowel adenocarcinoma (2) and jejunal vascular malformation (2). CONCLUSION: 64-slice multiphase CT-EG is a useful investigation in the evaluation of both occult and overt OGIB.

Effect of bed head elevation during sleep in symptomatic patients of nocturnal gastroesophageal reflux.

BACKGROUND AND AIM: Nocturnal gastro-esophageal reflux causes heartburn and sleep disturbances impairing quality of life. Lifestyle modifications, like bed head elevation during sleep, are thought to alleviate the symptoms of gastroesophageal reflux. We tested the hypothesis that bed head elevation might decrease recumbent acid exposure compared to sleeping in a flat bed. METHODS: Patients of symptomatic nocturnal reflux and documented recumbent (supine) reflux verified by esophageal pH test entered the trial. On day 1, baseline pH was measured while the patient slept on a flat bed. Then patients slept on a bed with the head end elevated by a 20-cm block for the next 6 consecutive days from day 2 to day 7. The pH test was repeated on day 2 and day 7. Each patient acted as his own control. RESULTS: Twenty of 24 (83.3%) patients with mean age of 36 ± 5.5 years completed the trial. The mean (± SD) supine reflux time %, acid clearance time, number of refluxes 5 min longer and symptom score on day 1 and day 7 were 15.0 ± 8.4 and 13.7 ± 7.2; P = 0.001, 3.8 ± 2.0 and 3.0 ± 1.6; P = 0.001, 3.3 ± 2.2 and 1.0 ± 1.2; P = 0.001, and 2.3 ± 0.6 and 1.5 ± 0.6; P = 0.04, respectively. The sleep disturbances improved in 13 (65%) patients. CONCLUSIONS: Bed head elevation reduced esophageal acid exposure and acid clearance time in nocturnal (supine) refluxers and led to some relief from heartburn and sleep disturbance.

Incidence of colorectal cancer in Kashmir valley, India.

BACKGROUND: There is wide variation in the incidence of colorectal cancer globally and also within the same country among different racial or ethnic groups. The present population-based study was undertaken to determine the incidence of colorectal cancer in Kashmiri population which is non-migratory and ethnically homogeneous having stable food habits. METHODS: Over a period of one year, all newly diagnosed and histological proved cases of colorectal cancer in all possible areas, where such patients are diagnosed and treated were prospectively registered. RESULTS: A total of 212 cases of colorectal cancers were registered; of them 113 (53.3%) originated in the colon and other 99 (46.7%) in rectum. Male to female ratio was 1.2:1. The crude incidence rate of colorectal cancer was 3.65/100,000; it was 3.78 in males, and 3.50/100,000 in females. The incidence rates for colorectal cancer in Muslims and Hindus were different. The crude incidence rate for colorectal carcinoma was highest for district Srinagar 6.19/100,000 (urban area) and lowest for district Kupwara (rural area) 1.59/100,000. The highest numbers of cases were detected in the age group 55-59 years (n = 34). The age-specific rate for colorectal carcinoma was highest in the age group 55-59 years (17.21/100,000), followed by 65-69 years (14.86/100,000). The age standardized incidence rate was 4.52/100,000 per year. The truncated age adjusted incidence rates in age group 35-64 years was 8.31/100,000; while that for colorectal carcinoma was 8.77/100,000 in males and 7.66/100,000 in females. CONCLUSION: We conclude that the incidence of colorectal cancer in Kashmir valley is similar to that reported in the rest of India.

Comparison of p.o. or i.v. proton pump inhibitors on 72-h intragastric pH in bleeding peptic ulcer.

BACKGROUND AND AIMS: After successful endoscopic hemostasis in bleeding peptic ulcer, addition of proton pump inhibitors reduce the rate of recurrent bleeding by maintaining intragastric pH at neutral level. The aim of the present study was to evaluate the effect of various proton pump inhibitors given through different routes on intragastric pH over 72 h after endoscopic hemostasis in bleeding peptic ulcer. METHODS: Ninety consecutive patients who had successful endoscopic therapy of bleeding peptic ulcer underwent 72-h continuous ambulatory intragastric pH study, were randomly assigned to receive p.o. omeprazole 80 mg bolus followed by 40 mg every 12 h for 72 h or i.v. 80 mg omeprazole followed by infusion 8 mg/h for 72 h. Oral pantoprazole 80 mg bolus followed by 80 mg every 12 h for 72 h or i.v. 80 mg pantoprazole followed by infusion of 8 mg/h for 72 h. Oral rabeprazole 80 mg bolus followed by 40 mg every 12 h for 72 h or i.v. 80 mg rabeprazole followed by infusion 8 mg/h for 72 h. Five patients received no treatment after successful endoscopic therapy and underwent 72-h pH study. RESULTS: Mean 72-h intragastric pH for p.o. omeprazole was 6.56 versus 6.93 for omeprazole infusion (P = 0.48). Mean 72-h intragastric pH for p.o. pantoprazole was 6.34 versus 6.32 for pantoprazole infusion (P = 0.62). Mean 72-h intragastric pH for rabeprazole p.o. was 6.11 versus 6.18 rabeprazole i.v. (P = 0.55). Mean 72-h pH for the no proton pump inhibitor group was 2.04. CONCLUSION: There was no significant difference among various proton pump inhibitors given through different routes on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer.

Vesicoperitoneal fistula--an unusual cause of tense ascites.

We report a 55-year-old man who developed tense ascites due to vesicoperitoneal fistula. He had undergone surgery 32 years ago for excision of an infected urachal cyst, the tract and the umbilicus.

Pantoprazole infusion as adjuvant therapy to endoscopic treatment in patients with peptic ulcer bleeding: prospective randomized controlled trial.

BACKGROUND AND AIM: Following successful endoscopic therapy in patients with peptic ulcer bleeding, rebleeding occurs in 20% of patients. Rebleeding remains the most important determinant of poor prognosis. We investigated whether or not administration of pantoprazole infusion would improve the outcome in ulcer bleeding following successful endoscopic therapy. METHODS: In this double-blind, placebo-controlled, prospective trial, patients who had gastric or duodenal ulcers with active bleeding or non-bleeding visible vessel received combined endoscopy therapy with injection of epinephrine and heater probe application. Patients who achieved hemostasis were randomly assigned to receive pantoprazole (80 mg intravenous bolus followed by an infusion at a rate of 8 mg per hour) or placebo for 72 h. The primary end-point was the rate of rebleeding. RESULTS: Rebleeding was lower in the pantoprazole group (8 of 102 patients, 7.8%) than in the placebo group (20 of 101 patients, 19.8%; P = 0.01). Patients in the pantoprazole group required significantly fewer transfusions (1 +/- 2.5 vs 2 +/- 3.3; P = 0.003) and days of hospitalization (5.6 +/- 5.3 vs 7.7 +/- 7.3; P = 0.0003). Rescue therapies were needed more frequently in the placebo group (7.8% vs 19.8%; P = 0.01). Three (2.9%) patients in the pantoprazole group and eight (7.9%) in the placebo group required surgery to control their bleeding (P = 0.12). Two patients in the pantoprazole group and four in the placebo group died (P = 0.45). CONCLUSION: In patients with bleeding peptic ulcers, the use of high dose pantoprazole infusion following successful endoscopic therapy is effective in reducing rebleeding, transfusion requirements and hospital stay.

Endoscopic ligation vs. sclerotherapy in adults with extrahepatic portal venous obstruction: a prospective randomized study.

BACKGROUND: Endoscopic sclerotherapy is a well-established treatment for bleeding esophageal varices, although it has a substantial complication rate. A prospective randomized trial was conducted to determine whether endoscopic variceal ligation is safer and more effective than sclerotherapy in adults with bleeding esophageal varices because of extrahepatic portal venous obstruction. METHODS: Thirty-six patients underwent sclerotherapy and 37 had band ligation. RESULTS: Ligation and sclerotherapy were equally effective for achieving variceal eradication (94.6% vs. 91.7%, respectively; p=0.67). However, ligation achieved eradication with fewer endoscopic sessions (3.7 [1.2] vs. 7.7 [3.3]; p <0.0001) and within a shorter time interval (50.1 [17.7] days vs. 99 [54.8] days; p <0.0001). In the ligation group, recurrent bleeding was less frequent (2.7% vs. 19.4%; p=0.028; however, Bonferroni correction for multiple testing removes this significance) and the rate of major complications was lower (2.7% vs. 22.2%; p=0.014). Total cost per patient was significantly higher in the sclerotherapy vs. the ligation group ($216.6 [71.8] vs. $182.6 [63.4]; p=0.035). During the follow-up period after variceal eradication, no significant differences were found between the sclerotherapy and the ligation groups with respect to recurrent bleeding (3% vs. 2.9%; p=1.0), esophageal variceal recurrence (9.1% vs. 11.4%; p=1.0), and formation of new gastric varices (9.1% vs. 14.3%; p=0.51). CONCLUSIONS: Variceal band ligation is superior to sclerotherapy, because it is less costly and achieves variceal eradication more quickly, with lower relative frequencies of recurrent variceal bleeding and complications.

Endoscopic management of early postoperative biliary ascariasis in patients with biliary tract surgery.

Bile leak and residual stones are well known complications of biliary tract surgery. In endemic areas of ascariasis, invasion of the biliary tract by roundworms during the early postoperative period is an infrequent but serious complication. The present study describes the endoscopic management of postoperative biliary ascariasis in 19 consecutive patients. There were 5 men and 14 women with a mean age of 33.3 +/- 6.3 years. All patients had undergone cholecystectomy, with choledocholithotomy and placement of a T-tube in 13 (68.4%) patients. Eight (42.1%) patients including two with T-tubes were acutely sick at referral. Altogether, 16 (84.2%) patients had widened papillae due to previous endoscopic sphincterotomy (3 patients) or recent dilatation of the sphincter of Oddi by Bake's dilators (13 patients). All patients with a T-tube in situ had undergone unsuccessful attempts to remove the worms by flushing saline through the T-tube. Endoscopic retrograde cholangiopancreatography was performed 4 to 16 days after biliary tract surgery and revealed roundworms in the common bile duct in 10 patients, in the hepatic ducts in 2, or in both ducts in 7. Three patients had coexisting biliary leakage: from the cystic duct stump in two and from a T-tube track in one. Endoscopic treatment consisted of extracting the worms from the biliary tree and placing stents in those with coexisting leakage. Endoscopic success was defined as complete worm extraction and resolution of biliary leakage and was achieved in all patients. Complications occurred in one (5.3%) patient. We concluded that endoscopic management is an effective, safe approach for extracting ascarids from the biliary tree during the early postoperative period. It reduces the hospital stay, avoids T-tube-related complications, and permits a postoperative complication to be treated using a nonsurgical method.

Fifteen-year follow up of endoscopic injection sclerotherapy in children with extrahepatic portal venous obstruction.

BACKGROUND AND AIM: Endoscopic sclerotherapy has emerged as an effective treatment for bleeding esophageal varices both in adults and children but the long-term outcome is poorly defined in children. The authors report a 15-year follow up of sclerotherapy in children with extrahepatic portal venous obstruction. METHODS: Between June 1982 and February 1992, 69 children with bleeding esophageal varices underwent sclerotherapy; variceal eradication was achieved in 63 (91.3%) patients, with procedure-related morbidity of 28.9% and mortality of 1.4%. Fifty-nine patients with variceal eradication were followed for between 10.4 and 20.1 years (mean, 15.1 +/- 3.1 years). RESULTS: After a median period of 3 years (range, 1.2-12.8 years), seven (11.9%) patients presented with recurrent bleeding (esophageal varices, four; gastric varices, two; and duodenal ulcer, one). Recurrent bleeding occurred in six of seven (85.7%) patients within the first 4 years of initial variceal eradication. Esophageal varices recurred in eight (13.6%) patients. Five of the seven patients with recurrent bleeding and all eight with recurrent varices were effectively treated with further sclerotherapy. Two patients with gastric variceal bleeding unresponsive to sclerotherapy underwent shunt surgery. Elective surgery was required in eight additional patients for reasons other than recurrent varices or bleeding. CONCLUSIONS: The authors conclude that (i) sclerotherapy is the ideal, safe and effective treatment for bleeding esophageal varices, that it prevented bleeding in 88.1% patients after variceal eradication and hence, should be included in primary management strategies; (ii) follow-up endoscopy should be performed on a yearly basis for the first 4 years after variceal eradication; and (iii) surgery is required as a complementary technique for patients with uncontrolled bleeding, painful splenomegaly, growth retardation and symptomatic portal biliopathy.

Endoscopic sphincterotomy in the management of bile duct stones in children.

OBJECTIVE: Endoscopic sphincterotomy (ES) is a widely accepted method of extracting bile duct stones (BDS) in young as well as in elderly patients. The present study was undertaken to assess the safety and efficacy of ES for the treatment of BDS in children, seven of whom were critically sick because of suppurative cholangitis or pancreatitis. METHOD: Over a period of 33 months, ES was performed in 16 consecutive children aged 7-16 yr with BDS. Nine patients had gallbladder in situ, and seven had previously undergone cholecystectomy. The coexisting abnormalities were gallstones and hepatic duct stones in one patient each and dead fragmented roundworms in 11 patients. Seven (five with an intact gallbladder and two cholecystectomized) patients presented with severe complications of BDS such as severe cholangitis in six and acute severe pancreatitis in one. RESULTS: ES was technically successful in all patients, and complete stone extraction was achieved in 15 (93.8%) patients. Complications were minor bleeding in one (6.3%) patient without mortality. One patient with coexisting gallstones underwent cholecystectomy at a later date. During a mean follow-up period of 4-32 months, one patient developed recurrent biliary symptoms because of biliary ascariasis. CONCLUSIONS: We conclude ES is a safe and an effective method of treating BDS in children with previous cholecystectomy, and in those presenting with severe complications of BDS, such as pyogenic cholangitis or acute pancreatitis regardless of the presence of gallbladder.

Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extrahepatic portal venous obstruction.

Endoscopic sclerotherapy is an effective treatment for bleeding esophageal varices, but it is associated with significant complications. Endoscopic ligation, a new form of endoscopic treatment for bleeding varices, has been shown to be superior to sclerotherapy in adult patients with cirrhosis. To determine the efficacy and safety of endoscopic sclerotherapy and ligation, the 2 methods were compared in a randomized control trial in 49 children with extrahepatic portal venous obstruction who had proven bleeding from esophageal varices. Twenty-four patients were treated with sclerotherapy and 25 with band ligation. No significant differences were found between the sclerotherapy and ligation groups in arresting active index bleeding (100% each) and achieving variceal eradication (91.7% vs. 96%, P =.61). Band ligation eradicated varices in fewer endoscopic sessions than did sclerotherapy (3.9 +/- 1.1 vs. 6.1 +/- 1.7, respectively, P <.0001). The rebleeding rate was significantly higher in the sclerotherapy group (25% vs. 4%, P =.049), as was the rate of major complications (25% vs. 4%, P =.049). After eradication, esophageal variceal recurrence was not significantly different in patients treated by ligation than by sclerotherapy (17.4% vs. 10%, P =.67). In conclusion, variceal band ligation in children is a safe and effective technique that achieves variceal eradication more quickly, with a lower rebleeding rate and fewer complications compared with sclerotherapy.