Effect of the BioEnterics intragastric balloon on weight, insulin resistance, and liver steatosis in obese patients.

BACKGROUND: In obese patients, positioning of the BioEnterics intragastric balloon (BIB) proved beneficial for weight loss, but the effect of the device on ameliorating some components of the metabolic syndrome associated with obesity remains uncertain. OBJECTIVE: To evaluate the effectiveness of BIB insertion on weight control and amelioration of components of the metabolic syndrome. DESIGN: A prospective intervention study performed at baseline, 6 months after BIB insertion, and after a mean (standard deviation [SD]) of 21 (3) months (range 14-26) of follow-up. SETTING: Division of Gastroenterology and Endoscopic Unit, "Casa Sollievo della Sofferenza" Hospital. PATIENTS: One hundred thirty obese patients with a mean (SD) weight of 118 (24) kg and mean (SD) body mass index (BMI) of 43 (8) kg/m(2). INTERVENTIONS: Positioning of BIB. MAIN OUTCOME MEASUREMENTS: Anthropometric and laboratory parameters. RESULTS: Overall, the mean (SD) weight and BMI decreased by 13.2 (8.2) kg and 5.1 (3.2) kg/m(2), respectively, compared with baseline. The mean glycemia, insulinemia, Homeostasis Model Assessment index, triglyceridemia, and alanine aminotransferase levels were significantly reduced. In the 91 responders (BMI decrease of > or = 3.5 kg/m(2)), the mean (SD) weight and BMI decreased by 16.4 (6.3) kg and 6.4 (2.3) kg/m(2), respectively, and severe liver steatosis decreased from 52% to 4% (P < .0001). On multivariate analysis, severe steatosis and the Homeostasis Model Assessment index were predictive of the response to BIB: odds ratios of 6.71 (95% CI, 2.23-20.19) and 3.18 (95% CI, 1.20-8.42). After a median follow-up of 22 months after BIB removal, 50% of responders maintained or continued to lose weight. LIMITATIONS: No sham-treated patients were included as comparative controls. CONCLUSIONS: Treatment was effective in inducing weight loss, improving liver steatosis, and restoring some components of the metabolic syndrome.

Fatal systemic venous air embolism during endoscopic retrograde cholangiopancreatography.

Hepatic portal venous air embolism is the rarest complication of gastrointestinal endoscopy, resulting from penetration of gas into the portal veins, and may occur during endoscopic retrograde cholangiopancreatography and endoscopic biliary sphincterotomy. The likely mechanism is intramural dissection of insufflated air into the portal venous system through duodenal vein radicles transected during the procedure. Hepatic portal air embolism may be fatal. Cerebral air embolism may also occur. So far 13 cases of air embolism after endoscopic retrograde cholangiopancreatography have been reported, with 4 cases of systemic spread that proved fatal. Death was due to pulmonary air embolism in 2 cases, and cerebral air embolism in another 2. We report on an additional such fatal case, concerning a 78-year-old male patient, who several years previously had undergone surgical gastroduodenal resection with cholecystectomy and papillotomy, and was admitted for recurrent ascending cholangitis secondary to bile duct stones. During the third endoscopic cholangioscopic procedure for removal of bile duct stones, sudden cardiopulmonary arrest occurred. Death was due to massive pulmonary air embolism. Cerebral air embolism was also found. Autopsy was performed. A spontaneous duodenobiliary fistula was found. On the basis of bench radiologic investigation (retrograde suprahepatic venography and anterograde portography), it was demonstrated that the air insufflated during duodenal endoscopy, which entered through the spontaneous duodeno-biliary fistula, penetrated into intrahepatic vein radicles injured secondarily to prolonged impaction of biliary sand and stones and infection, resulting in portal and hepatic venous gas and systemic air embolism.

Pancreatic duct stents in the prophylaxis of pancreatic damage after endoscopic retrograde cholangiopancreatography: a systematic analysis of benefits and associated risks.

METHODS: The efficacy of pancreatic stenting in the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) was evaluated by a meta-analysis of 6 controlled studies; 12 additional uncontrolled studies were analyzed for rates of associated risk. RESULTS: Post-ERCP pancreatitis (PEP) developed in 16.5% of controls, and in 5.1 or 9.6% of the stent group at the per-protocol (PP) or intention-to-treat (ITT) analyses. By analyzing only the 4 randomized trials, PEP developed in 24.1% of controls, and in 6.1 or 12.0% of the stented patients at the PP or ITT analyses. Risk was significantly lower in the stent group when compared with controls: OR 0.44 (95% CI 0.24-0.81). The absolute risk reduction is 12.0 (95% CI 3.0-21.0), the number needed to treat 8 (95% CI 5-34), and the publication bias 2. ORs for mild to moderate PEP were reduced in the stent group (OR = 0.537, 95% CI 0.283-1.021), as were those for severe PEP (OR = 0.123, 95% CI 0.021-0.726). Non-pancreatic complications were 4.2%, and included early stent migration (1.4%), perforations (0.4%), bleeding (1.4%), and infections (1.0%). CONCLUSION: Available trials show benefit for pancreatic stenting in the prophylaxis of PEP, but more randomized studies are needed before endorsing a routine use of this endoscopic procedure.

Incidence rates of post-ERCP complications: a systematic survey of prospective studies.

OBJECTIVES: To provide health-care providers, patients, and physicians with an exhaustive assessment of prospective studies on rates of complications and fatalities associated with endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We searched MEDLINE (1977-2006) for prospective surveys on adult patients undergoing ERCP. "Grey literature" was sought by looking at cited references to identify further relevant studies. Data on postprocedural pancreatitis, bleeding, infections, perforations, and miscellaneous events as well as their associated fatalities were extracted independently by two reviewers. Sensitivity analysis was performed to test for data consistency between multicenter versus single center studies, and old (1977-1996) versus recent (1997-2005) reports. RESULTS: In 21 selected surveys, involving 16,855 patients, ERCP-attributable complications totaled 1,154 (6.85%, CI 6.46-7.24%), with 55 fatalities (0.33%, CI 0.24-0.42%). Mild-to-moderate events occurred in 872 patients (5.17%, CI 4.83-5.51%), and severe events in 282 (1.67%, CI 1.47-1.87%). Pancreatitis occurred in 585 subjects (3.47%, CI 3.19-3.75%), infections in 242 (1.44%, CI 1.26-1.62%), bleeding in 226 (1.34%, CI 1.16-1.52%), and perforations in 101 (0.60%, CI 0.48-0.72%). Cardiovascular and/or analgesia-related complications amounted to 173 (1.33%, CI 1.13-1.53%), with 9 fatalities (0.07%, CI 0.02-0.12%). As compared with old reports, morbidity rates increased significantly in most recent studies: 6.27%versus 7.51% (P(c)= 0.029). CONCLUSIONS: ERCP remains the endoscopic procedure that carries a high risk for morbidity and mortality. Complications continue to occur at a relatively consistent rate. The majority of events are of mild-to-moderate severity.

Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis.

BACKGROUND: The prophylactic use of somatostatin or gabexate in patients undergoing ERCP is still controversial. OBJECTIVE: Our purpose was to update the meta-analysis on somatostatin (SS, 16 studies) or gabexate mesylate (GM, 9 studies) prophylaxis of post-ERCP pancreatitis and to run sensitivity analyses by subgrouping trials according to schedules of drug administration. MAIN OUTCOME MEASUREMENTS: Post-ERCP acute pancreatitis, hyperamylasemia, and pain. RESULTS: Heterogeneity was present among selected studies, which appeared eliminated when only 9 high-quality trials on SS and 5 randomized studies on GM were considered. After data were pooled from SS trials, pancreatitis occurred in 7.3% of controls versus 5.3% of treated patients, a nonsignificant effect (odds ratio [OR] = 0.73; 95% CI 0.54-1.006). The funnel plot showed asymmetry with a negative slope (P = .05). The meta-analysis produced negative results for either short- (<6 hours) or long-term (> or =12 hours) SS infusion, whereas a bolus injection proved effective (OR = 0.271; 95% CI 0.138-0.536), with a pooled absolute risk reduction of 8.2% (95% CI 4.4-12.0%). Postprocedural hyperamylasemia, but not pain, was significantly reduced (OR = 0.67, 95% CI 0.57-0.81). In controls and patients treated with GM, pancreatitis developed in 5.7% versus 4.8%, hyperamylasemia in 40.6% versus 36.9%, and pain in 1.7% versus 8.9%. All pooled ORs were nonsignificant: P = .34, .17, and .19, respectively. The meta-analysis produced no significant effect for either short-term (<6 hours) or long-term (>12 hours) GM administration. CONCLUSION: Short- or long-term infusion of SS or GM proved ineffective in reducing post-ERCP pancreatitis and pain. The beneficial effect of SS on postprocedural hyperamylasemia seems of marginal significance. When given as a bolus injection, SS maintains its promise in this field, but additional data are needed.

Antisecretory vs. antiproteasic drugs in the prevention of post-ERCP pancreatitis: the evidence-based medicine derived from a meta-analysis study.

Uncertainties still exist about the clinical benefit of pharmacological prevention of post-ERCP pancreatitis by either antisecretory drugs such as somatostatin and its long-acting analogue octreotide, or protease inhibitors such as gabexate mesilate. Recent, large-scale prospective studies have reported a fourfold reduction in acute pancreatitis as compared to a placebo with the prophylactic administration of either gabexate mesilate or somatostatin, whereas octreotide was found to be ineffective. An initial meta-analysis of all available controlled trials on this topic has confirmed these findings. The indiscriminate use of these drugs in all patients is unlikely to be cost-effective, but the selective use of prophylaxis for high-risk patients might be advocated. Moreover, inasmuch as 85% of complications developed within 4 to 6 hours of completing the ERCP, it would be reasonable to infuse drugs only for this limited length of time. A recent prospective trial, carried out on high-risk patients, has surprisingly documented a higher incidence, although a non-significant one, of pancreatitis in patients who received short-term prophylaxis with somatostatin or gabexate mesilate than those given a placebo: 11.5% and 8.1% vs. 6.5%, respectively. In order to explore this discrepancy, the original meta-analysis was updated by including data of this negative trial: heterogeneity among the trials was apparent. A careful scrutiny of the most recent studies has revealed differences in patient population, protocols of drug administration, technique and operator-related risk factors for complications among the trials, which could explain, by themselves, the contrasting results reported by the interventional studies. In conclusion, current literature does not support the prophylactic use of either somatostatin or gabexate mesilate for the prevention of ERCP-related pancreatic damage, even in patients deemed to be at high risk for complications. At present, post-ERCP complications (and pancreatitis) can be prevented efficaciously by appropriate selection of patients, mastering of the technique and operator competence.