Topical pharyngeal anesthesia with articaine for gastroscopy: a double-blinded, randomized cross-over study in healthy volunteers.

OBJECTIVES: The benefits of topical pharyngeal anesthesia for gastroscopy remain under debate. Articaine, a local anesthetic with fast onset and offset of action as well as low systemic toxicity, could be a promising choice for topical anesthesia. The objective of this study was to assess whether topical pharyngeal anesthesia with articaine is beneficial in sedated gastroscopy. MATERIALS AND METHODS: This randomized double-blinded cross-over study included nine volunteers who underwent two gastroscopies under conscious sedation. One was performed with topical pharyngeal anesthesia with articaine and the other with placebo. Hemodynamic parameters including autonomic nervous system state were recorded prior to and during the endoscopic procedure. The endoscopist and the volunteer assessed the endoscopy after the examination. RESULTS: Topical pharyngeal anesthesia with articaine resulted in less discomfort during esophageal intubation and higher patient satisfaction with the procedure. Topical pharyngeal anesthesia with articaine did not increase satisfaction or facilitate the procedure as rated by the endoscopist. There were no clinically relevant differences in hemodynamic parameters. CONCLUSION: The use of articaine for topical pharyngeal anesthesia results in less intubation-related discomfort and better satisfaction.

Assessing Patient Radiation Exposure in Endoscopic Retrograde Cholangiopancreatography: A Multicenter Retrospective Analysis of Procedural Complexity and Clinical Factors.

BACKGROUND AND AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) procedures can result in significant patient radiation exposure. This retrospective multicenter study aimed to assess the influence of procedural complexity and other clinical factors on radiation exposure in ERCP. METHODS: Data on kerma-area product (KAP), air-kerma at the reference point (Ka,r), fluoroscopy time, and the number of exposures, and relevant patient, procedure, and operator factors were collected from 2641 ERCP procedures performed at four university hospitals. The influence of procedural complexity, assessed using the American Society for Gastrointestinal Endoscopy (ASGE) and HOUSE complexity grading scales, on radiation exposure quantities was analyzed within each center. The procedures were categorized into two groups based on ERCP indications: primary sclerosing cholangitis (PSC) and other ERCPs. RESULTS: Both the ASGE and HOUSE complexity grading scales had a significant impact on radiation exposure quantities. Remarkably, there was up to a 50-fold difference in dose quantities observed across the participating centers. For non-PSC ERCP procedures, the median KAP ranged from 0.9 to 64.4 Gy·cm2 among the centers. The individual endoscopist also had a substantial influence on radiation dose. CONCLUSIONS: Procedural complexity grading in ERCP significantly affects radiation exposure. Higher procedural complexity is typically associated with increased patient radiation dose. The ASGE complexity grading scale demonstrated greater sensitivity to changes in radiation exposure compared to the HOUSE grading scale. Additionally, significant variations in dose indices, fluoroscopy times, and number of exposures were observed across the participating centers.

Occupational radiation dose from gastrointestinal endoscopy procedures with special emphasis on eye lens doses in endoscopic retrograde cholangiopancreatography.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) procedures may result in remarkable radiation doses to patients and staff. The aim of this prospective study was to determine occupational exposures in gastrointestinal endoscopy procedures, with a special emphasis on eye lens dose in ERCP. Methods Altogether 604 fluoroscopy-guided procedures, of which 560 were ERCPs belonging to four American Society for Gastrointestinal Endoscopy procedural complexity levels, were performed using two fluoroscopy systems. Personal deep-dose equivalent H p (10), shallow-dose equivalent H p (0.07), and eye lens dose equivalent H p (3) of eight interventionists and H p (3) for two nurse dosimeters were measured. Thereafter, conversion coefficients from kerma-area product (KAP) for H p (10), H p (0.07), and H p (3) were determined and dose equivalents per procedure to an operator and assisting staff were estimated. Further, mean conversion factors from H p (10) and H p (0.07) to H p (3) were calculated. Results The median KAP in ERCP was 1.0 Gy·cm 2 , with mobile c-arm yielding higher doses than a floor-mounted device ( P  < 0.001). The median H p (3) per ERCP was estimated to be 0.6 µSv (max. 12.5 µSv) and 0.4 µSv (max. 12.2 µSv) for operators and assisting staff, respectively. The median H p (10) and H p (0.07) per procedure ranged from 0.6 to 1.8 µSv. ERCP procedural complexity level ( P  ≤ 0.002) and interventionist ( P  < 0.001) affected dose equivalents. Conclusions Occupational dose limits are unlikely to be exceeded in gastrointestinal endoscopy practice when following radiation-hygienic working methods and focusing on dose optimization. The eye lens dose equivalent H p (3) may be estimated with sufficient agreement from the H p (10) and H p (0.07).

Endoscopic therapy of sporadic non-ampullary duodenal adenomas, single centre retrospective analysis.

INTRODUCTION: Although sporadic non-ampullary duodenal adenomas (SNADA) are rare, with the risk of progression to cancer, they deserve therapy. Endoscopic therapy of SNADA is effective, but with the increased risk of complications, endotherapy should be performed in high-volume units. The results of endotherapy of SNADA in our unit are presented. PATIENTS AND METHODS: A total of 97 patients with SNADA had endoscopic resection in 2005-2021 and control endoscopies between 3 and 24 months. Snare polypectomy, endoscopic mucosal resection (EMR), endoscopic band ligation (EBL) and endoloop were used (en bloc 37% and piecemeal 63%). In cases of residual/recurrent adenomas, endotherapy was repeated. RESULTS: The median size of the adenoma was 12 (5-60) mm and most polyps were sessile (25%) or flat (65%). Primary endotherapy eradicated adenomas in 57 (59%) cases. Residual and recurrence rates were 24% (n = 23) and 17% (n = 16) with successful endotherapy in 16 (70%) and 13 (81%) patients. Endotherapy was successful in 86 (89%) patients after a median (range) follow-up of 23 (1-166) months. Four out of 11 patients with failed endotherapy had surgery; seven patients were not fit for surgery. There were no disease-specific deaths or carcinoma. Eleven patients (11%) suffered from complications: perforation requiring surgery (n = 1), sepsis (n = 1), postprocedure bleeding (n = 7), cardiac arrest (n = 1) and coronary infarct (n = 1). The thirty-day mortality was zero. Colonoscopy was performed on 67 (69%) patients with neoplastic lesions in 33% patients during follow-up. CONCLUSIONS: Endotherapy of SNADA is effective and safe. Repeat endotherapy in residual and recurrent adenomas is successful. Careful patient selection is mandatory. Abbreviations: ASA: American Society of Anesthesiologist classification; BMI: body mass index; CT: computed tomography; EBL: endoscopic band ligation; EMR: endoscopic mucosal resection; ESD: endoscopic submucosal dissection; ET: endotherapy; FAP: familial adenomatous polyposis; F: female; LST: laterally spreading tumours; M: male; SD: standard deviation; SNADA: sporadic nonampullary duodenal adenoma.

Single-operator peroral pancreatoscopy in the preoperative diagnostics of suspected main duct intraductal papillary mucinous neoplasms: efficacy and novel insights on complications.

BACKGROUND: Distinguishing intraductal papillary mucinous neoplasms (IPMNs) from other pancreatic cystic lesions is essential since IPMNs carry the risk of becoming malignant. Differentiating the main pancreatic duct involving IPMNs (MD-IPMNs) through conventional imaging is deficient. Single-operator peroral pancreatoscopy (SOPP) represents a promising method offering additional information on suspected lesions in the pancreatic main duct (MD). We aimed to determine the role of SOPP in the preoperative diagnostics of suspected MD-IPMNs and identify factors contributing to SOPP-related complications. MATERIALS AND METHODS: In this primarily retrospective study, SOPPs were performed at three high-volume centers on suspected MD-IPMNs. Primary outcome was the clinical impact of SOPP to subsequent patient care. Additionally, we documented post-SOPP complications and analyzed several assumed patient- and procedure-related risk factors. RESULTS: One hundred and one (101) SOPPs were performed. Subsequent clinical management was affected due to the findings in 86 (85%) cases. Surgery was planned for 29 (29%) patients. A condition other than IPMN explaining MD dilatation was found in 28 (28%) cases. In 35 (35%) cases, follow-up with MRI was continued. Post-SOPP pancreatitis occurred in 20 (20%) patients and one of them was fatal. A decrease in odds of post-SOPP pancreatitis was seen as the MD diameter increases (OR 0.714 for 1.0 mm increase in MD diameter, CI 95% 0.514-0.993, p = 0.045). Furthermore, a correlation between lower MD diameter values and higher severity post-SOPP pancreatitis was seen (TJT = 599, SE = 116.6, z = - 2.31; p = 0.020). History of pancreatitis after endoscopic retrograde cholangiopancreatography was a confirmed risk factor for post-SOPP pancreatitis. Conclusions between complications and other risk factors could not be drawn. CONCLUSION: SOPP aids clinical decision-making in suspected MD-IPMNs. Risk for post-SOPP pancreatitis is not negligible compared to non-invasive imaging methods. The risk for pancreatitis decreases as the diameter of the MD increases.

Fully covered self-expanding metal stents for benign refractory pancreatic duct strictures in chronic pancreatitis.

Background: Pancreatic duct (PD) stricture is a common adverse event in chronic pancreatitis (CP). Primary treatment for refractory PD strictures is endotherapy (ET), including the insertion of multiple plastic stents. In addition, fully covered self-expandable metal stents (FC-SEMSs) have also been successfully used. More long-term studies are necessary to clarify the complication rate and efficiency, however. Methods: This retrospective study was comprised of 17 patients with symptomatic CP and refractory fibrotic main pancreatic duct (MPD) stricture treated with FC-SEMSs between 2010-2018 at the Helsinki University Hospital. Treated strictures were located in the pancreatic head. Technical success was defined as the accurate positioning of the stent and resolution of the MPD stricture. Clinical success was defined as pain relief at the end of the follow-up. Results: In 12 patients (71%), stricture resolution was accomplished. Clinical success was achieved in 12 patients (71%). The median duration of stenting was 169 days (range 15-804). Ten patients (58.8%) underwent a follow-up of two years or more. Early complications (≤7 days) occurred in two patients (12%): one pancreatitis and one cholestasis. Late complications (≥7 days) included severe abdominal pain (n = 2, 12%), pancreatitis (n = 3, 18%), cholestasis (n = 1, 6%) and stent migration (n = 7, 35%). Significant differences in stricture resolution and pain improvement were evident in patients with stent migration compared to patients without stent migration [1(14.3%) vs. 11(84.6%), p = .004 and 2(28.6%) vs. 11(84.6%), p = .022]. Conclusion: FC-SEMS placement is a safe and potentially effective treatment for this challenging group of patients. However, stent migration appears to affect the clinical and technical outcome.

Serum Serine Peptidase Inhibitor Kazal-Type 1, Trypsinogens 1 to 3, and Complex of Trypsin 2 and α1-Antitrypsin in the Diagnosis of Severe Acute Pancreatitis.

OBJECTIVES: We explored prediction of severe acute pancreatitis (AP) and development of organ dysfunction (OD). METHODS: Serum concentrations of serine peptidase inhibitor Kazal type 1 (SPINK1), trypsinogen 1, trypsinogen 2, and trypsinogen 3, complex between trypsin 2 and α1-antitrypsin, serum C-reactive protein, creatinine, and pancreatic amylase were measured in 239 AP patients with disease onset within 72 hours. RESULTS: SPINK1 distinguished most accurately patients who later developed severe AP. The area under the receiver operating characteristic curve for SPINK1 was 0.742, followed by trypsinogen 2 (0.726), complex between trypsin 2 and α1-antitrypsin (0.657), creatinine (0.656), trypsinogen 1 (0.652), trypsinogen 3 (0.557), and C-reactive protein (0.499). With a cutoff of 166 µg/L, SPINK1 had a specificity of 93%, a sensitivity of 48%, and diagnostic odds ratio of 11.52. In multivariate logistic regression analysis, only SPINK1 was an independent predictor of severe AP among patients presenting without OD on admission (P < 0.001). CONCLUSIONS: Plasma levels of the biomarkers and creatinine correlated with the severity of AP and development of OD. In patients presenting without OD at admission, SPINK1 was an independent marker for later development of severe AP.

An immunocapture-LC-MS-based assay for serum SPINK1 allows simultaneous quantification and detection of SPINK1 variants.

Pancreatic secretory trypsin inhibitor Kazal type 1 (SPINK1) is a 6420 Da peptide produced by the pancreas, but also by several other tissues and many tumors. Some mutations of the SPINK1 gene, like the one causing amino acid change N34S, have been shown to confer susceptibility to recurrent or chronic pancreatitis. Detection of such variants are therefore of clinical utility. So far SPINK1 variants have been determined by DNA techniques. We have developed and validated an immunocapture-liquid chromatography-mass spectrometric (IC-LC-MS) assay for the detection and quantification of serum SPINK1, N34S-SPINK1, and P55S-SPINK1. We compared this method with a time-resolved immunofluorometric assay (TR-IFMA) for serum samples and primer extension analysis of DNA samples. We used serum and DNA samples from patients with acute pancreatitis, renal cell carcinoma, or benign urological conditions. With the help of a zygosity score calculated from the respective peak areas using the formula wild-type (wt) SPINK1/(variant SPINK1 + wt SPINK1), we were able to correctly characterize the heterozygotes and homozygotes from the samples with DNA information. The score was then used to characterize the apparent zygosity of the samples with no DNA characterization. The IC-LC-MS method for SPINK1 was linear over the concentration range 0.5-1000 µg/L. The limit of quantitation (LOQ) was 0.5 µg/L. The IC-LC-MS and the TR-IFMA assays showed good correlation. The median zygosity score was 1.00 (95% CI 0.98-1.01, n = 11), 0.55 (95% CI 0.43-0.61, n = 14), and 0.05 (range 0.04-0.07, n = 3) for individuals found to be wt, heterozygous, and homozygous, respectively, for the N34S-SPINK1 variant by DNA analysis. When DNA samples are not available, this assay facilitates identification of the N34S- and P55S-SPINK1 variants also in archival serum samples.

Endoscopic Therapy of Biliary Injury After Cholecystectomy.

BACKGROUND: Iatrogenic bile duct injury (BDI) is a common complication after cholecystectomy. Patients are mainly treated endoscopically, but the optimal treatment method has remained unclear. AIMS: The aim was to analyze endoscopic treatment in BDI after cholecystectomy and to explore endoscopic sphincterotomy (ES), with or without stenting, as the primary treatment for an Amsterdam type A bile leak. METHODS: All patients referred to Helsinki University Hospital endoscopy unit due to a suspected BDI between the years 2004 and 2014 were included in this retrospective study. To collect the data, all ERC reports were reviewed. RESULTS: Of the 99 BDI patients, 94 (95%) had bile leak of whom 11 had concomitant stricture. Ninety-three percent of all patients were treated endoscopically. Seventy-one patients had native papillae and a leak in the cystic duct or peripheral radicals. They were treated with ES (ES group, n = 50) or with sphincterotomy and stenting (EST group, n = 21). There was no difference between the closure time of the fistula (p = 0.179), in the time of discharge from hospital (p = 0.298), or in the primary healing rate between the ES group and the EST group (45/50 vs 19/21 patients, p = 0.951). CONCLUSION: After the right patient selection, the success rate of endoscopic treatment can approach 100% for Amsterdam type A bile leak. ES is an effective and cost-effective single procedure with success rate similar to EST. It may be considered as a first-line therapy for the management of Amsterdam type A leaks.

Diclofenac Does Not Reduce the Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in Low-Risk Units.

BACKGROUND: Nonsteroidal anti-inflammatory drugs have an inhibitory role in pathogenesis of pancreatitis. Guidelines from the European Society of Gastrointestinal Endoscopy recommend routine rectal administration of 100 mg of diclofenac or indomethacin immediately before or after ERCP for all patients without contraindications. AIMS: Our aim was to evaluate the effect of diclofenac in preventing post-ERCP pancreatitis (PEP) in a high-volume, low-PEP-risk ERCP unit. METHODS: The rate and severity of PEP were compared in groups of 1000 historical controls prior to the routine use of diclofenac and in 1000 patients receiving 100 mg diclofenac before ERCP. RESULTS: PEP occurred in 56 (2.8%) of the 2000 patients, and the rate of the pancreatitis was 2.8% in control group and 2.8% in diclofenac group (p = 1.000). The PEP rate among the native papilla patients was 3.9% in control group and 3.6% in diclofenac group (p = 0.803). In subgroup analysis of patients with a high risk of PEP, diclofenac neither prevented PEP nor made its course milder. CONCLUSIONS: In an unselected patient population in a center with a low incidence of PEP, diclofenac seems to have no beneficial effect.

A prospective randomised study of dense Infinity cytological brush versus regularly used brush in pancreaticobiliary malignancy.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) with a cytological sample is a valuable tool in the diagnosis of the aetiology of biliary stricture. Our aim was to evaluate whether a more dense Infinity® cytological brush is more sensitive in diagnosing malignancy than the regularly used brush. PATIENTS AND METHODS: We recruited 60 patients with a biliary stricture suspicious for malignancy for a randomised controlled trial. Patients were randomly assigned to an Infinity® brush group (n = 30) and a regularly used cytology brush group (n = 30). All the patients had verified cancer during follow-up. RESULTS: Crossing the brush over the stricture was possible in each case without dilatation of the biliary duct. Brush cytology yield was good or excellent in 86.7% of cases with the Infinity® brush and 96.7% with the regular brush (p = 0.161). The cytological sample showed clear malignancy in three patients (10.0%) in the Infinity® group and in 12 (40.0%) patients of the regular brush group (p = 0.007). The cytological diagnosis was highly suspicious for malignancy or malignant in 14 patients (46.7%) in the Infinity® group and in 23 patients (76.7%) in the regular brush group (p = 0.017). The result was benign in 10 patients (33.3%) in the Infinity® group and in four patients (13.6%) in the regular brush group (p = 0.067). CONCLUSIONS: With the standardised technique, the sensitivity of brush cytology is fairly good. The dense Infinity® brush does not show any advantage regarding sensitivity compared with the conventional cytology brush.

Activated protein C retards recovery from coagulopathy in severe acute pancreatitis.

OBJECTIVES: Activated protein C (APC), an endogenous anticoagulant, has antithrombotic, fibrinolytic and anti-inflammatory properties. We recently conducted a controlled study (APCAP, activated protein C in severe acute pancreatitis) of APC treatment of patients with severe acute pancreatitis (SAP). Here we studied the effect of APC on the pivotal coagulation parameters of the surviving patients in the APCAP study. METHODS: The study consisted of 20 patients of whom 10 patients had received APC and 10 patients had received placebo. Coagulation parameters, physiological anticoagulants, thrombograms and circulating levels of IL-6 and CRP were determined on admission and at days 1, 3-4 and 6-7. RESULTS: During follow-up, the temporal levels of prothrombin time (PT) decreased and the temporal levels of thromboplastin time (TT) increased in placebo group (p< 0.001 for both), but not in APC group. The temporal levels of antithrombin (AT) increased less in APC group than in placebo group (p = 0.011). The shapes of the SAP patients' thrombograms were strongly deranged and were marginally affected by APC treatment. CONCLUSIONS: Coagulopathy in SAP, a complex phenomenon, is not alleviated by APC treatment. Rather, the patients receiving APC are heading toward normal homeostasis of coagulation slower than patients receiving placebo.

Assessment of indications for percutaneous endoscopic gastrostomy--development of a predictive model.

OBJECTIVE: Percutaneous endoscopic gastrostomy (PEG) is used for long-term enteral nutrition in neurological patients with dysphagia (NEUR), in head and neck cancer patients prior to chemoradiation therapy (head and neck malignancy group [HNM]), or in cases of oropharyngeal or esophageal tumor obstruction or stricture (OBSTR). Considerable morbidity and overall mortality is reported. Aim was to analyze the complication rates and mortality with PEG and to identify subgroups with poor outcomes. MATERIAL AND METHODS: Patients underwent PEG (n = 401) in a single tertiary care center. Indications, characteristics, and causes of death were recorded. RESULTS: Number of patients in groups: HNM 135 (34%), OBSTR 74 (18%), and NEUR 192 (48%); follow-up time median (interquartile range): 17 (39) months; the time PEG used for feeding: 4 (7) months. A total of 91 patients (23%) had 110 complications, 31 patients (8%) had early (≤30 days) complications, and 49 patients (12%) major complications. Two deaths (0.5%, 2 peritonitis) were related to PEG. The 30-day mortality was 11% (n = 47). According to multivariate analysis, an increased 30-day mortality was associated with ≥75 years of age, American Society of Anesthesiologists (ASA) class IV, a Charlson comorbidity index (CCI) ≥4, body mass index (BMI) <18.5, and ongoing antibiotic therapy. With this model, 95% specificity was obtained in the 30-day survival figures. CONCLUSION: The presented predictive model derived from our analysis may recognize patients with poor outcome when referred for PEG. The parameters in the present model (age, ASA class, CCI score, BMI, and data of ongoing antibiotic treatment) are easily measurable, and it is possible to integrate them into everyday work.

Treatment of abdominal compartment syndrome with subcutaneous anterior abdominal fasciotomy in severe acute pancreatitis.

BACKGROUND: Managing the abdominal compartment syndrome associated with severe acute pancreatitis by the open abdomen method is associated with considerable morbidity and resource utilization. METHODS: A technique of subcutaneous anterior abdominal fasciotomy is described for the first time in two patients with severe acute pancreatitis. RESULTS: Following the procedure, the intra-abdominal pressure decreased from 30 mmHg immediately to 23 mmHg and to a sustained level of 12-14 mmHg in the first patient, and from 35 mmHg immediately to 23 mmHg and to a sustained level of 14-19 mmHg in the second patient. CONCLUSIONS: The subcutaneous anterior abdominal fasciotomy is a promising method for safe and effective abdominal decompression with sustained effect and avoiding the morbidity associated with the alternative open abdomen techniques.

Surgery for colorectal cancer in a low-volume unit: assessment of key issues in the achievement of acceptable clinical results.

BACKGROUND: The maintenance of modern therapeutic principles requires a proper case load to achieve acceptable surgical results. This may obligate administrative reorganization to overcome these problems and to provide an adequate level of cancer surgery. AIM: To assess the surgical results of patients coming for surgery for colorectal cancer in a low-volume non-academic unit during the past 15 yr. METHODS: 458 consecutive patients referred for surgery between 1988 and 2001 in Kanta-Häme Central Hospital in Finland were analyzed regarding their disease, mode of surgery, and the immediate and long-term result. The data were collected from patient journals and from the National Centre of Statistics and analyzed in two successive periods. RESULTS: The number of patients with a localized disease (Dukes A + Dukes B) decreased during the followup from 49% to 45%. A curative procedure was achieved in 68% in the first half and in 73% in the second half of the observation period. The immediate mortality was 5% and 2% in the two periods, respectively. The corrected 5-year survival according to the Dukes Classification was 92% (A), 69% (B), 41% (C ), and 6% (D). In curative surgery for rectal cancer, the incidences of local recurrence decreased from 21% to 9% (NS) and the use of permanent colostomy from 59 to 42% (NS). CONCLUSIONS: Acceptable immediate and long-term results in curative surgery for colorectal cancer can be achieved in a low-volume surgical unit. Nevertheless, owing to the low volume, the improvement of the results obligates team-based institutional specialization and careful consideration about the extensiveness of the primary procedure in case of cancer obstruction.