P-suPAR may reflect the inflammatory response after pancreatic surgery.

BACKGROUND: Several different scoring systems have been developed to predict post-pancreatectomy complications. Currently used inflammatory markers are of only limited value in predicting complications after pancreatic surgery. Plasma soluble urokinase plasminogen activator receptor (P-suPAR) is a prognostic biomarker associated with different inflammatory conditions. The aim of this study was to investigate P-suPAR levels before and after pancreatic surgery. METHODS: One hundred and seventy-six patients evaluated for pancreatic surgery due to suspected malignant or premalignant lesion were recruited for this study at Tampere University Hospital between 2016 and 2021. P-suPAR was analyzed before the planned operation and on postoperative days (PODs) one and three. RESULTS: One hundred and thirty-three patients [median age 67 (range 33-84) years, 50 % male] underwent a pancreatic surgery procedure. Compared to preoperative values [median 3.7 (IQR 3.1-4.7) ng/mL], P-suPAR was significantly lower on PODs 1 [3.2 (2.5-3.9) ng/mL; p < 0.001] and 3 [3.2 (2.7-4.1) ng/mL; p < 0.001]. P-suPAR on POD 1 was significantly lower in patients with postoperative pancreatic fistula (POPF) [2.6 (2.1-3.4) ng/mL] than in patients with no POPF [3.2 (2.6-3.8) ng/mL; p = 0.007]. Similar decreases in P-suPAR values were seen in patients with postoperative acute pancreatitis (POAP) and surgical site infection (SSI). CONCLUSIONS: After pancreatic surgery, P-suPAR level on POD 1 is significantly lower in patients with POPF, POAP or SSI. P-suPAR is decreased after pancreatic resection in all patients. This type of postoperative P-suPAR profile has not previously been described, and may reflect the compensatory anti-inflammatory reaction following the initial systemic inflammatory reaction caused by surgical trauma.

Unconventional treatment of inoperable biliary IPMN with an oesophageal stent in the common bile duct: case report.

Biliary intraductal papillary mucinous neoplasm (IPMN) is a rare biliary neoplasia preferably treated with oncologic resection. Endoscopic radio frequency (RF) ablation may be used as a palliative measure. We present a rare case, where heavy co-morbidities prevented surgery. Continuous mucus production caused recurrent episodes of severe cholangitis. Several ERCPs (endoscopic retrograde cholangio pancretography) were necessary due to recurrent biliary obstruction. RF ablation was not effective in the dilated common bile duct without a stricture. Standard biliary stents failed due to either migration or occlusion. When other options failed, an exceptional decision was made: a covered large diameter oesophageal stent was inserted in ERCP into the bile duct to secure bile flow and stop mucus production. Digital cholangioscopy was crucial adjunct to standard ERCP in endoscopic management. The palliative treatment method was successful: there were no stent-related adverse events or readmissions for cholangitis. The follow-up in the palliative care lasted until patient's last 10 months of lifetime.

Initial management of suspected biliary injury after laparoscopic cholecystectomy.

Although rare, iatrogenic bile duct injury (BDI) after laparoscopic cholecystectomy may be devastating to the patient. The cornerstones for the initial management of BDI are early recognition, followed by modern imaging and evaluation of injury severity. Tertiary hepato-biliary centre care with a multi-disciplinary approach is crucial. The diagnostics of BDI commences with a multi-phase abdominal computed tomography scan, and when the biloma is drained or a surgical drain is put in place, the diagnosis is set with the help of bile drain output. To visualize the leak site and biliary anatomy, the diagnostics is supplemented with contrast enhanced magnetic resonance imaging. The location and severity of the bile duct lesion and concomitant injuries to the hepatic vascular system are evaluated. Most often, a combination of percutaneous and endoscopic methods is used for control of contamination and bile leak. Generally, the next step is endoscopic retrograde cholangiography (ERC) for downstream control of the bile leak. ERC with insertion of a stent is the treatment of choice in most mild bile leaks. The surgical option of re-operation and its timing should be discussed in cases where an endoscopic and percutaneous approach is not sufficient. The patient's failure to recover properly in the first days after laparoscopic cholecystectomy should immediately raise suspicion of BDI and this merits immediate investigation. Early consultation and referral to a dedicated hepato-biliary unit are essential for the best outcome.

Wait-and-see strategy is justified after ERCP and endoscopic sphincterotomy in elderly patients with common biliary duct stones.

BACKGROUND: Older patients with simultaneous main bile duct and gallbladder stones, especially those with high-surgical risks, create a common clinical dilemma. After successful endoscopic removal of main bile duct stones, should these patients undergo laparoscopic cholecystectomy to reduce risk of recurrent biliary events? In this population-based cohort study, we report long-term outcomes of a wait-and-see strategy after successful endoscopic extraction of main bile duct stones. METHODS: Consecutive patients 75 years or older undergoing endoscopic stone extraction without subsequent cholecystectomy in two tertiary academic centers between January 2010 and December 2018 were included. Primary outcome measure was recurrence of biliary events. Secondary outcome measures were operation-related morbidity and mortality. RESULTS: A total of 450 patients (median age, 85 years; 61% female) were included, with a median follow-up time of 36 months (0-120 months). Recurrent biliary events occurred in 51 patients (11%), with a median time from index hospital admission to recurrence of 307 days (12-1993 days). The most common biliary event was acute cholecystitis (7.1%). Twelve patients had cholangitis (2.7%) and two biliary pancreatitis (0.4%). Only one patient (0.4%) underwent surgery due to later gallstone-related symptoms. Eighteen patients (4.0%) required endoscopic intervention and 16 (3.5%) underwent surgery. There were no operation-associated deaths or morbidity among those undergoing later surgical or endoscopic interventions. CONCLUSION: In elderly patients, it is relatively safe to leave gallbladder in situ after successful sphincterotomy and endoscopic common bile duct stone removal. In elderly and frail patients, a wait-and-see strategy without routine cholecystectomy rarely leads to clinically significant consequences. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Bile-volatile organic compounds in the diagnostics of pancreatic cancer and biliary obstruction: A prospective proof-of-concept study.

Objectives: Detection of volatile organic compounds (VOCs) from bodily fluids with field asymmetric waveform ion mobility spectrometry (FAIMS) and related methods has been studied in various settings. Preliminary results suggest that it is possible to detect prostate, colorectal, ovarian and pancreatic cancer from urine samples. In this study, our primary aim was to differentiate pancreatic cancer from pancreatitis and benign tumours of the pancreas by using bile samples obtained during endoscopic retrograde cholangiopancreatography (ERCP). Secondarily, we aimed to differentiate all pancreatic region malignancies from all other kinds of benign causes of biliary obstruction. Methods: A bile sample was successfully aspirated from 94 patients during ERCP in Tampere University Hospital. Hospital and patient records were prospectively followed up for at least two years after ERCP. Bile samples were analysed using a Lonestar chemical analyser (Owlstone, UK) using an ATLAS sampling system and a split-flow box. Diagnoses and corresponding data from the analyses were matched and divided into two subcategories for comparison. Statistical analysis was performed using linear discriminant analysis, support vector machines, and 5-fold cross-validation. Results: Pancreatic cancers (n=8) were differentiated from benign pancreatic lesions (n=9) with a sensitivity of 100%, specificity of 77.8%, and correct rate of 88%. All pancreatic region cancers (n=19) were differentiated from all other kinds of benign causes of biliary obstruction (n=75) with corresponding values of 21.1%, 94.7%, and 80.7%. The sample size was too small to try to differentiate pancreatic cancers from adjacent cancers. Conclusion: Analysing bile VOCs using FAIMS shows promising capability in detecting pancreatic cancer and other cancers in the pancreatic area.

Preoperative measures predicting outcome after pancreatic resection in aged patients.

BACKGROUND AND OBJECTIVE: High-risk surgery on aged patients raises challenging ethical and clinical issues. The aim of this study was to analyze the preoperative factors associated with severe complications and returning home after pancreatic resection among patients aged ⩾ 75 years. PATIENTS AND METHODS: Patients aged ⩾ 75 years undergoing pancreatic resection in 2012-2019 were retrospectively searched from the hospital database. Preoperative indices (Clinical Frailty Scale, Skeletal Muscle Index, Geriatric Nutritional Risk Index, Charlson Comorbidity Index, and National Surgical Quality Improvement Program risk for severe complications) were determined. Postoperative outcome was evaluated by incidence of Clavien-Dindo 3b-5 complications, rate of returning home, and 1-year survival. RESULTS: A total of 95 patients were included. American Society of Anesthesiologists Class 3-4 covered 50%, Clinical Frailty Scale > 3 22%, Charlson Comorbidity Index > 6 53%, and a sarcopenic Skeletal Muscle Index 51% of these patients. The National Surgical Quality Improvement Program risk for severe complications was higher than average among 21% of patients. Geriatric Nutritional Risk Index showed high risk among 3% of them. In total, 19 patients (20%) experienced a severe (Clavien-Dindo 3b-5) complication. However, 30- and 90-day mortality was 2.1%. Preoperative indices were not associated with severe complications. Most patients (79%) had returned home within 8 weeks of surgery. Not returning home was associated with severe complications (p = 0.010). CONCLUSIONS: The short-term outcome after pancreatic resection of fit older patients is similar to that of younger, unselected patient groups. In these selected patients, the commonly used preoperative indexes were not associated with severe complications or returning home.

The European evidence-based guidelines on pancreatic cystic neoplasms (PCN) in clinical practice: The development of relative and absolute indications for surgery during prospective IPMN surveillance.

INTRODUCTION: The European evidence-based guidelines on PCN recommend surveillance for IPMN patients who are fit for surgery but who have no indication for immediate surgery. Our aim was to demonstrate the feasibility of the new guidelines in clinical practice. METHODS: This is a prospective cohort study of patients included in the IPMN register in Tampere University Hospital, Finland. IPMN was diagnosed from January 1, 2013 to December 31, 2018. Patients were analyzed for surveillance and indications for surgery according to the European guidelines on PCN. RESULTS: Out of 128 patients in register 23 was decided to operate upfront and 105 patients were included in the surveillance programme. Invasive carcinoma was found in 4/23 of operated patients. Median follow-up time was 26 months (6-69). Median size of the cyst at the beginning and end of the surveillance was 16 mm (4-58 mm). During surveillance 0/105 (0.0%) patients had or developed an absolute indication for surgery. Relative indication for surgery was present in 8/105 (7.6%) patients in the beginning surveillance and 9/105 (8.6%) patients developed at least one relative indication for surgery during surveillance. From the surveillance cohort 2/105 patients were operated. Surveillance was abandoned in 15/105 (14.1%) patients all due to poor general condition or other medical conditions. CONCLUSIONS: In clinical practice, surveillance of IPMN according to the European guidelines on PCN is feasible. Among our patients 16% were detected to have relative indications for surgery during the median 26 (range 3-135) months of surveillance. Nearly 15% became surgically unfit during surveillance period.

Perioperative hydrocortisone treatment reduces postoperative pancreatic fistula rate after open distal pancreatectomy. A randomized placebo-controlled trial.

BACKGROUND: Postoperative pancreatic fistula (POPF) is the most common complication after distal pancreatectomy (DP). In a recent RCT on pancreaticoduodenectomy (PD), perioperative hydrocortisone (HC) treatment reduced Clavien-Dindo (C-D) III-V complications. The aim of this study was to investigate whether perioperative HC treatment reduces the overall complications and clinically significant POPF after distal pancreatectomy (DP). METHODS: Fourty consecutive patients undergoing DP were randomized to receive intravenous HC 100mg/placebo every eight hours until the second postoperative day. Thirty-one patients were completed with DP and received HC/placebo every 8 h for two days postoperatively. The primary endpoint was overall complications (C-D III-V) and the secondary endpoint was the development of clinically significant POPF. RESULTS: Pancreatic duct diameter, operative time and blood loss were similar in the groups. Ninety-day mortality was zero. With HC treatment the rates of C-D III-V complications tended to be lower compared to the placebo group (5.9% vs 21.4%, p = 0.034). The rate of grade B/C POPF was significantly reduced with HC treatment compared to the placebo group (5.9% vs. 42.9%, p = 0.028). CONCLUSION: Perioperative HC treatment may have a favourable effect on overall major complications after open DP. HC treatment reduces the incidence of clinically significant POPF after open DP.

Characteristics and long-term survival of resected pancreatic cystic neoplasms in Finland. The first nationwide retrospective cohort analysis.

BACKGROUND: Pancreatic cystic neoplasms (PCN) are being found increasingly in imaging studies. Even though the characteristics of PCN lesions have been studied extensively in single and multicentre settings, nationwide data is lacking. The aim of this study was to determine the nationwide epidemiologic characteristics and long-term survival of all resected PCNs. METHODS: For this retrospective cohort analysis, all PCNs operated on in Finland during the period 2000-2008 were identified. Data was collected from all patients: on demographics, comorbidities, symptoms, radiological findings, surgical procedures, complications, histopathological diagnoses and survival. Incomplete pathology reports and any uncertain diagnoses were re-assessed. Survival data was collected after a five-year follow-up period. RESULTS: The final database included 225 patients with operated PCN. After reviewing the incomplete pathology reports, in 44 cases the original diagnosis was changed, mostly from MCN to IPMN. The most common histopathological diagnoses were IPMN (94/225; 50/225 MD-IPMN, 30/225 MX-IPMN and 14/225 BD-IPMN), SCN (41/225) and MCN (40/225). Overall, 53/225 (23.6%) of the tumours were malignant. Malignancy was detected in MD-IPMN 29/50 (58%), MX-IPMN 10/30 (33.3%), MCN 12/40 (30%), BD-IPMN 2/14 (14.3%) patients. Median 5-year survival for all patients was 77%: 87% in patients without malignancy, 77% with HGD and 27% in patients with a malignant resected PCN. CONCLUSION: One fourth of the PCNs operated on nationwide were malignant, with a five-year survival of 27%, compared to overall survival of 87% in patients with non-malignant disease and 77% in those with HGD. Detecting - and operating on - a PCN before the malignant transfer remains a great challenge.

Biodegradable biliary stents preferable to plastic stent therapy in post-cholecystectomy bile leak and avoid second endoscopy.

BACKGROUND: The treatment of post-cholecystectomy bile leak is endoscopic retrograde cholangiography (ERC) with plastic stent (PS) insertion combined with external drainage. Self-expanding biodegradable biliary stents (BDBS) have only recently become available. AIM: The aim was to compare success rate, adverse events and costs of BDBS with PS in the treatment of post-cholecystectomy cystic duct leak Materials and methods: Patients recruited prospectively for treatment with BDBS during the period 2014-2017 were compared to a control group treated with PS in a non-randomized setting. RESULTS: Altogether 32 patients (median age 68, range 33-88, 59% male) were treated for Strasberg A bile leak over a period of 3.5 years, accounting for 1.8% of all ERCs. Eight patients were treated with BDBS and 24 with PS. Treatment with BDBS was safe; rate of readmissions and 30-day adverse events were 13% in both groups. There was no statistical difference in the clinical success rate. All cases with laparoscopic lavation or re-ERC with stent exchange occurred in the PS group. Total drain output was lower in BDBS patients (330ml vs 83ml, p=.002). All PS patients required another endoscopy for stent removal, whereas all BDBS patients were spared repeated endoscopy. CONCLUSION: Treatment of cystic duct leak with BDBS is highly successful and as safe as traditional treatment with PS. The most obvious benefit of BDBS is that it avoids stent removal. The lower drain output after ERC with a trend for fewer unplanned interventions may indicate more efficient leak resolution with the large bore BDBS.

A systematic review of biodegradable biliary stents: promising biocompatibility without stent removal.

Biodegradable self-expanding stents are an emerging alternative to standard biliary stents as the development of endoscopic insertion devices advances. The aim was to systematically review the existing literature on biodegradable biliary stents. In-vivo studies on the use of biodegradable stents in the biliary duct were systematically reviewed from 1990 to 2017. Despite extensive research on the biocompatibility of stents, the experience so far on their clinical use is limited. A few favorable reports have recently been presented on endoscopically and percutaneously inserted self-expanding biodegradable polydioxanone stents in benign biliary strictures. Another potential indication appears to be postcholecystectomy leak of the cystic duct. The main benefit of biodegradable stents is that stent removal can be avoided. The biocompatibility of the current biodegradable stent materials, most prominently polydioxanone, is well documented. In the few studies currently available, biodegradable stents are reported to be feasible and safe, also in humans. The initial results of the endoscopic use of these stents in benign biliary stricture management and for treating postcholecystectomy bile leaks are promising. Further controlled studies on long-term clinical results and cost-effectiveness are needed.

A pilot study of endoscopically inserted biodegradable biliary stents in the treatment of benign biliary strictures and cystic duct leaks.

BACKGROUND AND AIMS: Self-expanding biodegradable biliary stents (BDBSs) have recently become available for use in endoscopic retrograde cholangiography (ERC). The aim was to evaluate the effectiveness and safety of novel BDBSs in iatrogenic cystic duct leaks and benign biliary strictures (BBSs). METHODS: Patients providing informed consent were recruited for the prospective study. Braided self-expanding poly-dioxanone BDBSs were inserted using ERC during from 2014 to 2016. Repeated liver function tests and magnetic resonance imaging were performed during follow-up. The main outcomes were treatment success and adverse events. RESULTS: Thirteen patients, 5 women, median age 67 years (range, 43-79) underwent BDBS insertion for iatrogenic cystic duct leak (n = 7) or BBS (n = 6). Stent insertion using ERC was successful in all cases. All bile leaks were treated uneventfully with BDBSs. In BBSs, the clinical success rate of BDBS therapy was 83% in a median of 21 months of follow-up (range, 14-25). Early ERC-related adverse events included 1 cholangitis (8%) and 1 pancreatitis (8%), both in the stricture group. During the first 90 days, 23% of patients were readmitted for mild cholangitis. CONCLUSIONS: The short- and long-term safety of endoscopically inserted poly-dioxanone BDBSs was satisfactory. The management of cystic duct leaks and benign distal common bile duct strictures was highly successful. Episodes of mild cholangitis during stent indwelling seemed to be typical of BDBSs. The advantage of BDBSs is the avoidance of repeated endoscopy for stent removal. (Clinical trial registration number: NCT02353286.).

Can we prevent post-ERCP pancreatitis?

Endoscopic retrograde cholangiopancreatography (ERCP) is the primary method for treating cholestasis and biliary tract gallstones. Although noninvasive imaging has replaced ERCP in diagnostics, ERCP remains the mainstay in collecting diagnostic specimens from the biliary tract. ERCP carries a risk of post-ERCP pancreatitis, which can vary from mild to life-threatening. Difficult cannulation is the most important risk factor for pancreatitis. Careful patient selection and adequate endoscopy training are the foundation of safe ERCP practice. Current evidence supports the routine use of prophylactic rectal NSAID in all patients to prevent post-ERCP pancreatitis.

Patients with resected, histologically re-confirmed pancreatic ductal adenocarcinoma (PDAC) can achieve long-term survival despite T3 tumour or nodal involvement. The Finnish Register Study 2000-2013.

BACKGROUND: Long-term survival of patients with operated pancreatic ductal adenocarcinoma (PDAC) has been associated with resection status, disease stage and centralisation. However, no previous reports are available about long-term survivors of PDAC with confirmed histology covering an entire nation. Our aim was to analyze retrospectively confirmed long-term survivors of PDAC operated on in Finland 2000-2008. METHOD: PDAC patients operated between 2000 and 2008 were selected from Finnish patient registers and archives. Histological slides of patients with over four-year survival were re-evaluated by an expert pancreatic pathologist. From the confirmed PDAC patients, demographic, oncologic and operative parameters were recorded. The cut-point of survival was 31.12.2013. RESULTS: Out of the 598 patients operated on and originally diagnosed with PDAC, 52 of the long-term survivors (LTS) were confirmed as having had true PDAC. The four-year survival rate in high volume centres (HVC) was 13.0% and 6.7% elsewhere (p = 0.017). Five-year survival rate was 7.2%. After multivariate analysis only the size of the tumour persisted as prognostic factor for over four-year survival. Among LTSs, 50% of patients had stage IIB tumour and 40% had a R1 resection without difference with patients with shorter survival. The use of adjuvant therapy did not differ between the groups. CONCLUSION: This is the largest single-nationwide cohort of long-term survivors with confirmed PDAC. Comprehensive pathological evaluation is mandatory for an adequate PDAC diagnosis and true survival analysis. Long-term survival can be achieved even in T3 patients with nodal involvement and may be explained by favorable tumour biology.

Endoscopic biodegradable biliary stents in the treatment of benign biliary strictures: First report of clinical use in patients.

The first clinical experience of endoscopically inserted polydioxanone biodegradable biliary stents (BDBS) in the treatment of benign biliary strictures is reported. Two patients with a benign common bile duct stricture were endoscopically treated with 8-mm-bore BDBS during endoscopic retrograde cholangiography. Both BDBS insertions were technically successful and without adverse events. At 6 months, the stricture resolution was excellent and BDBS degradation was predicted in repeated magnetic resonance imaging. The first experience with endoscopic BDBS seems promising in the treatment of benign biliary strictures. During 6 months of follow up, BDBS seemed sufficient for remodeling and resolution of strictures. Further studies are needed to confirm the effectiveness of biodegradable biliary stents in endoscopic management of benign biliary strictures.

Safety and Efficacy of Acute Endoscopic Retrograde Cholangiopancreatography in the Elderly.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a frequent procedure in elderly patients. AIMS: We aimed to determine the safety and efficacy of acute ERCP in older patients. METHODS: A prospectively managed, hospital-based registry containing all ERCP procedures and complications at a tertiary referral center was used to form the study population, which consisted of consecutive elderly (≥65 years) patients undergoing acute ERCP during the 5-year study period. Indications, details, outcome, and complications of the procedure were analyzed in relation to patient age, gender, and co-morbidities. RESULTS: A total of 480 elderly patients (median age 78; range 65-97; 48 % men) underwent 531 ERCPs during the study period. The most common indications were bile duct stones (56.1 %) and biliary obstruction caused by malignancy (33.7 %). Successful stone extraction was achieved in 72.8 %, and with an additional, planned ERCP in 96.6 % of the patients. Post-ERCP complications developed in 3.4 % of the patients. These included pancreatitis in 1.7 %, hemorrhage in 0.6 %, and duodenal perforation in 0.2 % of the patients. One of these (0.2 %) was considered severe as this patient required invasive treatments and prolonged hospital stay. The risk of complications was associated with chronic obstructive pulmonary disease and difficult cannulation. Procedure-related mortality was zero, but overall 30-day mortality was 10 %, being 24 % in the patients with malignancy. CONCLUSIONS: ERCP can be safely and efficaciously performed on elderly patients. The high mortality should be taken into consideration when selecting therapeutic options.

Biodegradable biliary stents have a different effect than covered metal stents on the expression of proteins associated with tissue healing in benign biliary strictures.

BACKGROUND: Benign biliary strictures (BBS) are primarily treated endoscopically with covered self-expandable metal stents (CSEMS). Biodegradable biliary stents (BDBS) may be the future of endoscopic therapy of BBS. The aim was to assess the expression of proteins related to tissue healing in BBS compared with the intact bile duct (BD), and to study the protein expression after therapy with CSEMS or BDBS. METHODS: Pigs with ischemic BBS were endoscopically treated either with BDBS or CSEMS. Samples were harvested from pigs with intact BD (n = 5), untreated BBS (n = 5), and after six months of therapy with BDBS (n = 4) or CSEMS (n = 5) with subsequent histologic analysis. Two-dimensional electrophoresis with protein identification was performed to evaluate protein expression patterns. RESULTS: In BBS, the expression of galectin-2 and annexin-A4 decreased, compared to intact BD. Treatment with biodegradable stents normalized galectin-2 level; with CSEMS therapy it remained low. Transgelin expression of intact BD and BBS remained low after BDBS treatment but increased after CSEMS therapy. Histologic analysis did not show unwanted foreign body reaction or hyperplasia in the BD in either group. CONCLUSIONS: The expression of proteins related to tissue healing in BBS is different after treatment with biodegradable stents and CSEMS. Treatment with biodegradable stents may bring protein expression towards what is seen in intact BD. BDBS seem to have a good biocompatibility.

Biodegradable biliary stent in the endoscopic treatment of cystic duct leak after cholecystectomy: the first case report and review of literature.

BACKGROUND: The preferred therapy for simple postcholecystectomy biliary leak consists of percutaneous drainage and biliary stent insertion under endoscopic retrograde cholangiopancreatography (ERCP). With a novel endoscopic insertion device, a biodegradable biliary stent (BDBS) may be used in the treatment of a cystic duct leak without repeated endoscopy for stent removal. The objective of this article was to report the first case of endoscopic insertion of BDBS for postoperative bile leak and assess its feasibility and safety. PATIENT AND METHODS: A 64-year-old man with a postoperative leak from the cystic duct stump was treated with ERCP, biliary sphincterotomy, and insertion of a self-expandable 40- × 8-mm polydixanone BDBS (Ella CS, Hradec Králové, Czech Republic) after insertion of a percutaneous drain. RESULTS: Endoscopic insertion of BDBS was successful and uncomplicated. On Day 7 after ERCP, the patient was in good condition, no signs of bile leak or inflammation were observed, and the percutaneous drain was removed. At 3 months, magnetic resonance imaging showed that the BDBS was patent and in the right location. At 6 months, the stent had expectedly degraded. CONCLUSIONS: A novel endoscopic insertion device with a polydixanone BDBS appears feasible in treating disorders of the human biliary duct. BDBS now offers an encouraging option for endoscopic therapy of bile leaks.