Antibiotic prophylaxis and post-procedure infectious complications in endoscopic retrograde cholangiopancreatography with peroral cholangioscopy.

Background and study aims Single-operator peroral cholangioscopy (SOC) has gained increasing attention in modern biliary and pancreatic therapy and diagnosis. This procedure has shown higher rates of infectious complications than conventional endoscopic retrograde cholangiopancreatography (ERCP); therefore, many guidelines recommend antibiotic prophylaxis (AP). However, whether AP administration decreases infectious or overall adverse events (AEs) has been little studied. We aimed to study whether AP affects post-procedure infectious or overall AEs in ERCP with SOC. Patients and methods We collected data from the Swedish Registry for Gallstone Surgery and ERCP (GallRiks). Of the 124,921 extracted ERCP procedures performed between 2008 and 2021, 1,605 included SOC and represented the study population. Exclusion criteria were incomplete 30-day follow-up, ongoing antibiotic use, and procedures with unspecified indication. Type and dose of antibiotics were not reported. Post-procedure infectious complications and AEs at 30-day follow-up were the main outcomes. Results AP was administered to 1,307 patients (81.4%). In this group, 3.4% of the patients had infectious complications compared with 3.7% in the non-AP group. The overall AE rates in the AP and non-AP groups were 14.6% and 15.2%, respectively. The incidence of cholangitis was 3.1% in the AP group and 3.4% in the non-AP group. Using multivariable analysis, both infectious complications (odds ratio [OR] 0.92, 95% confidence interval [CI] 0.54-1.57) and AEs (OR 0.87, 95% CI 0.65-1.16) remained unaffected by AP administration. Conclusions No reduction in infectious complication rates and AEs was seen with AP administration for SOC. The continued need for AP in SOC remains uncertain.

Antibiotic prophylaxis and its effect on postprocedural adverse events in endoscopic retrograde cholangiopancreatography for primary sclerosing cholangitis.

Background and Aim: Primary sclerosing cholangitis (PSC) is characterized by multiple strictures of the biliary tree. Patients with PSC frequently require repeated endoscopic retrograde cholangiopancreatography (ERCP) procedures. These procedures are encumbered by an increased incidence of infectious adverse events such as cholangitis. Evidence regarding whether antibiotic prophylaxis (AP) should be administered is sparse; however, prophylaxis is recommended. We aimed to determine whether AP affects the rate of postprocedural infectious and overall adverse events. Methods: We conducted a retrospective cohort study and extracted all ERCP procedures with indicated PSC performed between 1 January 2006 and 31 December 2019, which were registered in the Swedish Registry for Gallstone Surgery and ERCP (GallRiks). The exclusion criteria were incomplete 30-day follow-up, non-index procedures, or ongoing antibiotics. The main outcomes were postprocedural infectious adverse events and overall adverse events at the 30-day follow-up. Results: A total of 2144 procedures with indication of PSC were eligible for inclusion. AP was administered in 1407 (66%) of these procedures. Patients receiving AP were slightly younger (44 vs 46 years, P = 0.005) and had more comorbidities (ASA ≥3, 19.8% vs 13.6%; P  < 0.001). Procedures with AP demonstrated an infectious adverse event rate of 3.3% compared to 4.5% for non-AP procedures (P = 0.19). Postprocedural infectious adverse events (odds ratio [OR] 0.76, 95% confidence interval [CI] 0.48-1.21) and overall adverse events (OR 0.79, 95% CI 0.60-1.04) did not differ between AP and non-AP. Conclusion: Patients with PSC who undergo ERCP have the same frequency of adverse events regardless of whether AP was used.

Bile leakage and the number of metal clips on the cystic duct during laparoscopic cholecystectomy.

BACKGROUND AND OBJECTIVE: The most common way of closing the cystic duct in laparoscopic cholecystectomy is by using metal clips (>80%). Nevertheless, bile leakage occurs in 0.4%-2.0% of cases, and thus causes significant morbidity. However, the optimal number of clips needed to avoid bile leakage has not been determined. The primary aim of this study was to evaluate bile leakage and post-procedural adverse events after laparoscopic cholecystectomy concerning whether two or three clips were used to seal the cystic duct. METHODS: Using a retrospective observational design, we gathered data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (ERCP) (GallRiks). From 2006 until 2019, 124,818 patients were eligible for inclusion. These were nested to cohorts of 75,322 (60.3%) for uncomplicated gallstone disease and 49,496 (39.7%) with complicated gallstone disease. The cohorts were grouped by the number (i.e. two or three) of metal clips applied to the proximal cystic duct. The main outcome was 30-day bile leakage and post-procedural adverse events. RESULTS: No significant differences surfaced in the rate of bile leakage (0.8% vs 0.8%; P = .87) or post-procedural adverse events (three clips, 5.7% vs two clips, 5.4%; P = .16) for uncomplicated gallstone disease. However, for complicated disease, bile leakage (1.4% vs 1.0%; P < .001) and post-procedural adverse events (10.2% vs 8.6%; P < .001) significantly increased when the cystic duct was sealed with three clips compared with two. CONCLUSIONS: Because no differences in the rates of bile leakage or adverse events emerged in uncomplicated gallstone disease when a third clip was applied, a third clip for additional safety is not recommended in such cases. On the contrary, bile leakage and adverse events increased when a third clip was used in patients with complicated gallstone disease. This finding probably indicates a more difficult cholecystectomy rather than being caused by the third clip itself.

Antibiotic prophylaxis in ERCP with failed cannulation.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) with failed biliary cannulation is associated with a high rate of adverse events, but the role of prophylactic antibiotics remains unclear. The primary aim was to investigate if prophylactically administered antibiotics affect the frequency of overall adverse complications in patients where biliary cannulation fails during ERCP. The secondary aim was to investigate if specific infectious complications, also were affected by the antibiotic prophylaxis. MATERIALS AND METHODS: We analysed data from 96,818 ERCPs (2006-2018), from the Swedish National Quality Registry of Cholecystectomy and ERCP (GallRiks), excluding ERCPs with successful cannulation (n = 88,743), missing data (n = 2,014), or on-going antibiotic therapy (n = 1,062). RESULTS: In total 4,996 procedures were included, 2,124 received (42.5%) and 2,872 (57.5%) did not receive antibiotic prophylaxis. There were fewer overall complications in the group receiving prophylaxis (13.6% vs. 17.1%, p < .001), which corresponded to a 24% adjusted odds reduction in the multivariable analysis (odds ratio [OR] 0.76; 95% confidence interval [CI] 0.65-0.89). In the prophylaxis group, there was a lower overall rate of infectious complications (2.1% vs. 3.2%; p = .038; OR 0.68; 95% CI 0.47-0.98) and abscesses (0.8% vs. 1.4%; p = .040; OR 0.54; 95% CI 0.31-0.96). However, no significant differences were seen in the rate of cholangitis (1.3% vs. 1.7%; p = .182; OR 0.74; 95% CI 0.46-1.18). CONCLUSION: This national quality registry study of ERCPs with failed cannulation showed a significant reduction in overall and infectious complications when prophylactic antibiotics were administered.

Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study.

BACKGROUND AND STUDY AIMS: Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities. PATIENTS AND METHODS: In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group. The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications. RESULTS: The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19 % vs. 0 %; P  = 0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72 % vs. 52 %), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12 % vs. 3.7 %); however, none of these differences in postoperative adverse events reached statistical significance. CONCLUSION: This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile drainage, as assessed by the amount of bacteria in the intraoperatively collected bile. However, some data in favor of SEMS were observed among the clinical secondary outcomes variables (preoperative stent exchange rates) without increases in local inflammatory reactions.

The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study.

BACKGROUND AND OBJECTIVES: The role of prophylactic pancreatic stenting (PS) in preventing post-endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis (PEP) has yet to be determined. Most previous studies show beneficial effects in reducing PEP when prophylactic pancreatic stents are used, especially in high-risk ERCP procedures. The present study aimed to address the use of PS in a nationwide register-based study in which the primary outcome was the prophylactic effect of PS in reducing PEP. METHODS: All ERCP-procedures registered in the nationwide Swedish Registry for Gallstone Surgery and ERCP (GallRiks) between 2006 and 2014 were studied. The primary outcome was PEP but we also studied other peri- and postoperative complication rates. RESULTS: Data from 43,595 ERCP procedures were analyzed. In the subgroup of patients who received PS with a total diameter ≤ 5 Fr, the risk of PEP increased nearly four times compared to those who received PS with a total diameter of >5 Fr (OR 3.58; 95% CI 1.40-11.07). Furthermore, patients who received PS of >5 Fr and >5 cm had a significantly lower pancreatitis frequency compared to those with shorter stents of the same diameter (1.39% vs 15.79%; p = 0.0033). CONCLUSIONS: PS with a diameter of >5 Fr and a length of >5 cm seems to have a better protective effect against PEP, compared to shorter and thinner stents. However, in the present version of GallRiks it is not possible to differentiate the exact type of pancreatic stent (apart from material, length and diameter) that has been introduced, so our conclusion must be interpreted with caution.

The H.O.U.S.E. classification: a novel endoscopic retrograde cholangiopancreatography (ERCP) complexity grading scale.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging endoscopic procedure, harboring a wide range of complexities within every single investigation. Classifications of the complexity of ERCP have been presented, but do not include modern endoscopic treatment modalities. In order to be able to target resources and compare the results of different endoscopic centers, a new complexity grading system for ERCP is warranted. This study launches a new complexity grading scale for ERCP-the H.O.U.S.E.-classification. METHODS: The medical record of every patient undergoing ERCP 2009-2011 at the Karolinska University Hospital was reviewed, regarding the complexity of the procedure, and categorized into one out of three-grades in the HOUSE classification system, and concomitantly graded according to the Cotton grading system. All ERCP-procedures were also registered in the Swedish registry for gallstone surgery and ERCP (GallRiks) and correlations between the grading systems and procedure related variables as well as outcomes were made. RESULTS: Between 2009 and 2011, 2185 ERCPs were performed at the Karolinska University Hospital, Huddinge. One thousand nine hundred fifty-four of those were index-ERCPs. Another 23 patients were excluded due to lack of postoperative complication registrations, leaving 1931 ERCP procedures to be analyzed. The procedure times were 40 ± 0.7, 65 ± 1.5 and 106 ± 3.2 min, respectively (HOUSE 1-3). The corresponding pancreatitis rates were 3.4, 7.0 and 6.8% and the postoperative complication rates 11.1, 15.7 and 12.8%, respectively. CONCLUSIONS: The HOUSE-classification is a novel grading scale for ERCP-complexity. The system can be implemented in clinical practice to allocate resources and allow the comparisons of results between different endoscopic centers. Further studies are warranted to further sharpen this instruments validitity and general clinical relevance.

The role of antibiotic prophylaxis in routine endoscopic retrograde cholangiopancreatography investigations as assessed prospectively in a nationwide study cohort.

OBJECTIVE: Risk factors for complications after endoscopic retrograde cholangiopancreatography (ERCP) with emphasis on the potential advantage of the use of prophylactic antibiotics were studied in a national population-based study cohort. MATERIALS AND METHODS: All ERCP procedures registered in the Swedish Registry of Gallstone Surgery and ERCP (GallRiks) between May 2005 and June 2013 were analyzed. Patients with ongoing antibiotic treatment, incomplete registration or those who had not undergone an index ERCP were excluded. Risk factors for adverse events were analyzed. RESULTS: Data from 47,950 ERCPs were collected, but after applying the exclusion criteria, 31,188 examinations were analyzed. In the group receiving prophylactic antibiotics, the postoperative adverse event rate was 11.6% compared with 14.2% in the group without antibiotics. The odds ratio (OR) for the risk of postoperative adverse events in patients receiving prophylactic antibiotics was 0.74 (95% confidence interval [CI]: 0.69-0.79). When analyzing a subgroup of 21,893 ERCPs for the three most common indications (common bile duct stones, malignancy, and obstructive jaundice), the beneficial effect of prophylactic antibiotics on adverse events remained (OR = 0.76; 95% CI: 0.70-0.82). Further, in the subgroup of patients with obstructive jaundice, the administration of prophylactic antibiotics had a beneficial effect on septic complications (OR = 0.76; 95% CI: 0.58-0.97). CONCLUSION: The risk of adverse events after ERCP is reduced 26% if antibiotics are given prophylactically during ERCP investigations, as suggested by data gained from this national population-based study. However, in absolute terms, the reduction in adverse events by prophylactic antibiotics is modest (2.6%).