Stent Drainage Research Articles

Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study

Background and AimsBiliary drainage by endoscopic retrograde cholangiography (ERCP) in patients with malignant distal bile duct obstruction (MBO) is frequently associated with complications, such as pancreatitis, hampering patient outcome. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is a promising alternative in patients with MBO but is associated with a worrisome risk of stent dysfunction. Placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, may decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates. MethodsProspective single center pilot study in patients with a pathology confirmed MBO without gastric-outlet obstruction. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent bile duct dilatation, or cholangitis. The study was registered in clinicaltrials.gov (registry number NCT05595122). ResultsOverall, 27 consecutive patients eligible for EUS-CDS were enrolled. The placement of a LAMS was successful in 24/27 patients (89%), and placement of FCSEMS through the LAMS was successful in 20/24 (83%), in the remaining 4 patients a coaxial double-pigtail plastic stent was placed. In 2 of these 20 patients there was persistent jaundice requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success. ConclusionsThis study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the design of LAMS may further reduce the rate of stent dysfunction.

S148 The Utility of Lumen-Apposing Metal Stents Combined With Coaxial Double-Pigtail Plastic Stents for Endoscopic Ultrasound-Guided Transluminal Drainage of Pancreatic Fluid Collections

S148 The Utility of Lumen-Apposing Metal Stents Combined With Coaxial Double-Pigtail Plastic Stents for Endoscopic Ultrasound-Guided Transluminal Drainage of Pancreatic Fluid Collections

Reconstructive interventions on bile ducts in patients with benign obstructive jaundice

Aim. To evaluate immediate and long-term results of surgical reconstruction of the biliary system in various types of benign obstructive jaundice.Materials and methods. The study enrolled 110 patients with choledocholithiasis, iatrogenic biliary strictures, common bile duct strictures, as well as strictures of biliodigestive and biliobiliary anastomoses. Patients were divided into 3 groups. Group 1 included 43 patients with multiple choledocholithiasis and bile duct dilatation >15 mm. Group 2 enrolled 35 patients with multiple choledocholithiasis and hepaticolithiasis who were intraoperatively diagnosed with stricture, injury, or pressure ulcers of the common bile duct wall. Group 3 included 32 patients with cicatricial and iatrogenic biliary strictures. The immediate and long-term results of surgical treatment were compared.Results. In group 1, the survival rate comprised 89.4%, the average duration of surgery amounted to 137 minutes, complications involved wound infection, bile leakage, bile peritonitis. In group 2, the survival rate accounted for 91.4%, the average duration of surgery comprised 192 minutes; strictures of biliodigestive anastomosis were detected in the remote period, and reconstructive surgeries were performed. Group 3 revealed the survival rate of 100%, the average duration of surgery of 215 minutes, and no complications in the long term.Conclusion. The diameter of the common bile duct, its wall changes, size of gallstones, signs of cholangitis, patency of the bile papilla, and localization of biliary stricture determine the surgical tactics, when performing biliary reconstruction in patients with non-cancerous obstructive jaundice. In case minimally invasive surgery is found impossible under conditions of multiple choledocholithiasis, common bile duct diameter >15 mm, and preservation of its wall, choledocholithotomy with Kerr drainage is considered to be optimal. In case of damage to the CBD wall and patency of the bile papilla, preference shall be given to hepaticoenterostomy. Bile duct reconstruction with stent drainage is indicated for treatment of cicatricial and iatrogenic biliary strictures.

The composition of the stent microbiome is associated with morbidity and adverse events during endoscopic drainage therapy of pancreatic necroses and pseudocysts.

Development of pancreatic necroses or pseudocysts are typical complications of pancreatitis and may require endoscopic drainage therapy using metal or plastic stents. Microbial infection of these lesions poses a major challenge. So far, the composition and significance of the microbial colonization on drainage stents are largely unknown although it may impact outcomes during endoscopic drainage therapy. A total of 26 stents used for drainage of pancreatic lesions were retrieved and the stent microbiome was determined by 16S rRNA gene sequencing. Additional analysis included comparison of the stent microbiome to the intracavitary necrosis microbiome as well as scanning electron microscopy (SEM) and micro-computed tomography (μCT) imaging of selected metal or plastic stents. The stent microbiome comprises a large proportion of opportunistic enteric pathogens such as Enterococcus (14.4%) or Escherichia (6.1%) as well as oral bacteria like Streptococcus (13.1%). Increased levels of opportunistic enteric pathogens were associated with a prolonged hospital stay (r = 0.77, p = 3e-06) and the occurrence of adverse events during drainage therapy (p = 0.011). Higher levels of oral bacteria were associated (r = -0.62, p = 8e-04) with shorter durations of inpatient treatment. SEM and μCT investigations revealed complex biofilm networks on the stent surface. The composition of the stent microbiome is associated with prolonged hospital stays and adverse events during endoscopic drainage therapy, highlighting the need for effective infection control to improve patient outcomes. In addition to systemic antibiotic therapy, antimicrobial stent coatings could be a conceivable option to influence the stent microbiome and possibly enhance control of the necrotic microflora.

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768. ENDOSCOPIC MANAGEMENT OF COMPLEX THORACIC AORTA ANEURYSMAL SAC AND ENDOGRAFT INFECTION ASSOCIATED WITH AORTOESOPHAGEAL FISTULA

Abstract Background Aortoesophageal fistula (AEF) is a rare but life-threatening condition. Secondary AEF is a complex pathology occurring after thoracic aorta surgery with prosthetic graft, with an incidence of 1.6%. However, this is likely to rise with the increasing number of thoracic endovascular aortic repair (TEVAR) being performed. Management of secondary AEF is more challenging due to presence of adhesions in the pleural space, co-existing endograft infection and poor physiology of this group of patients. Definitive surgery carries high mortality rate and not all patients are suitable candidates. We review a case of secondary AEF with thoracic endograft infection managed non-operatively. Methods Our patient is a 70 years old man with a background of Stanford type A aortic dissection managed with ascending aorta and hemi-arch replacement with Dacron graft. Six years later, he had frozen elephant trunk reconstruction due to aneurysmal dilatation. Three months later, he underwent TEVAR for descending thoracic aorta aneurysm. Post-operation, he was diagnosed with Flavonifractor plautii bactaeremia secondary to infected aneurysmal sac and aortic stent graft and was initiated on antimicrobial therapy. During this time patient also developed recurrent episodes of haemoptysis. Bronchoscopy excluded an aortobronchial fistula and Oesophago-gastro-duodenoscopy (OGD) confirmed AEF at 25 cm from incisors. Results After discussion with a multidisciplinary team and patient, endoscopic management was chosen over surgery. Initial endoscopic closure of AEF with over-the-scope-clip appeared satisfactory but repeat OGD showed recurrence of new AEF which was partially closed with clips. Repeat imaging showed worsening mediastinal infection with larger gas-containing cavity. OGD was repeated with contrast demonstrating fistulous connection between the oesophagus and aneurysmal sac. A 7-French 4 cm double pigtail (DPT) stent was deployed into the sac under fluoroscopy to allow for trans-oesophageal drainage. Repeat imaging showed improvement in infection (Figure 1). Patient underwent endoscopic exchange of DPT stent 2 months after the initial insertion. Conclusion Definitive surgery for secondary AEF includes drainage of infection, explantation of infected endograft and aortic and oesophageal reconstruction. Oesophagectomy is preferred over primary repair of oesophageal defect. Not all patients will be suitable candidates for radical surgery and a non-operative approach may be required. Our patient likely has dense pleural and mediastinal adhesions from previous surgeries and thus, repeat surgery will be more challenging with increased risk of complications. However, if his mediastinal infection fails to resolve despite a period of DPT stent drainage, definitive surgery involving McKeown minimally invasive oesophagectomy with substernal gastric pull up would be required. Figure 1: Image A shows a large cavity with air and coalescent locules (arrow) prior to insertion of DPT stent. Image B shows a collapsed cavity (arrow) after DPT stent insertion.

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial

BackgroundEndoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.MethodsThe WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.DiscussionThe WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.Trial registrationClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Consensus guidelines on the diagnosis and treatment of pancreatic pseudocyst and walled-off necrosis from a Chinese multiple disciplinary team expert panel.

To prepare a set of practice guidelines to standardize the entire process, from diagnosis to treatment and follow-up, for pancreatic pseudocysts and walled-off necrosis. Thirty-six experts in the fields of digestive endoscopy, pancreatic surgery, interventional radiology, and others presented their opinions via discussions in online conferences by referring to the patient, intervention, comparison, and outcomes principles and then reviewed the evidence and statements using the Delphi method to reach a consensus. The consensus of >80% was finally achieved for the items. The experts discussed and reached a consensus on 29 statements including 10 categories: (1) definition and classification, (2) imaging and endoscopic diagnosis, (3) therapeutic implications, (4) surgical therapy, (5) percutaneous catheter drainage, (6) endoscopic retrograde cholangiopancreatography, (7) EUS-guided drainage, (8) stent selection for EUS-guided drainage, (9) complication related to stents for cyst drainage, and (10) drug treatment and follow-up. This consensus based on the clinical experience of experts in various fields and international evidence-based medicine further standardizes the multidisciplinary diagnosis and treatment processes for pancreatic pseudocysts and walled-off necrosis.

A glaucoma micro-stent with diverging channel and stepped shaft structure based on microfluidic template processing technology

BackgroundMinimally invasive glaucoma surgery (MIGS) has experienced a surge in popularity in recent years. Glaucoma micro-stents serve as the foundation for these minimally invasive procedures. Nevertheless, the utilization of these stents still presents certain short-term and long-term complications. This study aims to elucidate the creation of a novel drainage stent implant featuring a diverging channel, produced through microfluidic template processing technology. Additionally, an analysis of the mechanical properties, biocompatibility, and feasibility of implantation is conducted.ResultsThe stress concentration value of the proposed stent is significantly lower, approximately two to three times smaller, compared to the currently available commercial XEN gel stent. This indicates a stronger resistance to bending in theory. Theoretical calculations further reveal that the initial drainage efficiency of the gradient diverging drainage stent is approximately 5.76 times higher than that of XEN stents. Notably, in vivo experiments conducted at the third month demonstrate a favorable biocompatibility profile without any observed cytotoxicity. Additionally, the drainage stent exhibits excellent material stability in an in vitro simulation environment.ConclusionsIn summary, the diverging drainage stent presents a novel approach to the cost-effective and efficient preparation process of minimally invasive glaucoma surgery (MIGS) devices, offering additional filtering treatment options for glaucoma.

Comparative Efficacy of Magnetic Resonance Cholangiopancreatography vs. Percutaneous Transhepatic Cholangiography With Percutaneous Transhepatic Biliary Drainage Stenting in Evaluating Obstructive Jaundice: A Prospective Study in South India.

Introduction Obstructive jaundice due to proximal biliary obstruction presents significant diagnostic and therapeutic challenges. Accurate and timely diagnosis is essential for effective management. Objective/aim This study aimed to evaluate and compare the diagnostic accuracy of magnetic resonance cholangiopancreatography (MRCP) and percutaneous transhepatic cholangiography (PTC) along with percutaneous transhepatic biliary drainage (PTBD) stenting in obstructive jaundice, while also incorporating the comparison of ultrasonography (USG) and computed tomography (CT) findings. Materials and methods A prospective study was conducted at a tertiary healthcare center in South India from January 2020 to June 2022. Comprehensive diagnostic evaluations were performed using USG, contrast-enhanced computed tomography (CECT), MRCP, and PTC. The diagnostic outcomes from USG and CECT were initially assessed, followed by MRCP for every patient. These results were then compared with PTC, focusing on identifying the causes and levels of biliary obstruction. Results Fifty patients with suspected obstructive jaundice were included in the study. The study predominantly involved patients aged between the fourth and eighth decades (80%). Choledocholithiasis was identified as the leading cause (30%). MRCP demonstrated superior sensitivity in identifying both the cause (80%) and level (88%) of obstruction. It was particularly effective in detecting hilar masses with 100% sensitivity. Conversely, PTC, while less sensitive in detection, offered the advantage of simultaneous therapeutic intervention through stenting, with a sensitivity rate of 93% in detecting hilar masses. Conclusion MRCP outperforms PTC in diagnostic sensitivity for obstructive jaundice caused by proximal biliary obstruction. However, the advantage of PTC lies in its capacity for immediate therapeutic intervention via stent placement, addressing both diagnostic and treatment needs.

Study on the application of self-fixing and self-detachable drainage stent in pancreaticojejunostomy

Objectives: To evaluate the efficacy and safety of the self-fixing and self-detachable drainage stent in pancreaticojejunostomy and to provide supportive data for the follow clinical trials. Methods: This is an experimental research in animals which completed from February 2022 to September 2022. A self-fixing and self-detachable pancreaticojejunostomy drainage stent was designed for Hong's pancreaticojejunostomy technique based on the theory of "fistula healing" in pancreaticojejunostomy. Ten biocompatibility tests were completed in vitro before this study. Twenty-five Bama minipigs were selected and double-ligated in the neck of the pancreas to dilate the distal main pancreatic duct. Twenty-three of them were successfully modelled and divided into three groups by a stratified random method: pancreaticojejunostomy drainage stent group (referred to as stent group) with 11 pigs, pancreatic duct to jejunal mucosa anastomosis group (referred to as manual suture group) with 8 pigs, sham operation group with 4 pigs. The anastomic time,amylase content in postoperative abdominal drainage fluid and the tolerable pressure value of pancreaticojejunostomy were compared between the stent group and the manual suture group. An abdominal X-ray fluoroscopy examination was adopted to detect the detach time of the stent. A postoperative pathological examination was performed to verify the healing time,the type of treatment and the stricture rate of pancreaticojejunostomy. Quantitative data was analyzed by independent sample t-test. The classified data were analyzed by Fisher's exact test. Results: There were no significant differences in the diameter of the pancreatic duct and pancreatic texture,the time of pancreaticojejunostomy,the amylase content in postoperative peritoneal drainage fluid,and the tolerable pressure value of the pancreaticojejunostomy between the stent group and the manual suture group(all P>0.05). Abdominal X-ray fluoroscopy showed that the stents gradually detached and were removed from the body 21 days after operation,and all stents were detached in the follow 3 months after operation. Pancreaticojejunostomy healed 7 days after operation based on fistula formation in the stent group,and 14 days in the manual suture group. The incidence of anastomotic stricture within 35 days after operation was 2/8 in the stent group and 6/8 in the manual suture group (Fisher's exact test: P=0.132). Conclusion: The stent method is safer and simpler than the manual suture method in pancreaticojejunostomy of Bama minipigs, with shorter anastomotic healing time and lower stricture rate.

The role of MRCP for preventing pancreatic fluid collection recurrence after EUS-guided drainage of walled-off necrosis

Pancreatic fluid collections (PFCs) may recur after initial successful endoscopic drainage of walled-off necrosis (WON), most commonly due to disconnected pancreatic duct syndrome (DPDS). The primary aim of this study was to assess the role of MRCP for identifying DPDS to guide appropriate management and prevent PFC recurrence. Patients with WON undergoing lumen-apposing metal stent drainage of a PFC were retrospectively identified and categorized as those with MRCP versus those without MRCP before removal of transmural stents. Data on patient demographic characteristics, procedural details, cross-sectional imaging, and recurrence rates were collected through chart review. A total of 121 patients with WON were identified, of whom 44 (36.4%) had an MRCP before transmural stent removal. In patients without MRCP, 13 (16.8%) of 77 had PFC recurrence versus 0 of 44 (0%; P= .003) in those with MRCP. MRCP identified DPDS in 12 (27.2%) patients, all of whom were managed with indefinite drainage with double-pigtail plastic stents without recurrence. In the group without MRCP, PFCs recurred at a median interval of 284 days (interquartile range, 182-618 days) after transmural stent removal. Among the 13 patients with PFC recurrence, 11 (85%) had undiagnosed DPDS detected on subsequent imaging, of whom 9 were subsequently managed with indefinite double-pigtail plastic stents, with no further PFC recurrence. Patients with WON who underwent MRCP before transmural stent removal had a lower rate of PFC recurrence largely due to the identification of DPDS with appropriate endoscopic management.

Biliary spontaneous dislodgement spiral stent for short-term biliary drainage in patients undergoing complete stone removal: A randomized controlled study.

Biliary spontaneous dislodgement spiral stent for short-term biliary drainage in patients undergoing complete stone removal: A randomized controlled study.

Outcomes of 6-mm diameter fully covered self-expandable metal stents for preoperative biliary drainage in pancreatic cancer.

10-mm self-expandable metal stents (SEMSs) are commonly used for preoperative biliary drainage in pancreatic cancer. However, smaller diameter SEMSs have attracted attention with the attempt to reduce stent-related adverse events (AEs). We retrospectively analyzed consecutive borderline resectable pancreatic cancer patients who underwent neoadjuvant therapy and fully covered SEMS (FCSEMS) placement from April 2015 to May 2023. The primary outcome was stent-related non-event rate (NER), which was defined as the rate of completion of surgery without developing any preoperative events (recurrent biliary obstruction [RBO] or stent-related AEs). Secondary outcomes included stent-related AEs, causes of RBO, and cumulative incidence of RBO. Risk factors for pancreatitis, RBO, and stent migration were also examined. A total of 76 patients were included (6-mm group: 23; 10-mm group: 53). Stent-related NER (57% vs. 64%, p = 0.610), stent-related AEs (4% vs. 15%, p = 0.263), overall RBO rates (39% vs. 23%, p = 0.168), cumulative incidence of RBO (hazard ratio, 2.24; 95% confidence interval, 0.95-5.25; p = 0.065) were not significantly different between the two groups. Tumor involvement of the pancreatic duct was identified as a risk-reducing factor for pancreatitis, while an FCSEMS diameter of 6 mm was not identified as a risk factor for RBO and stent migration. Stent-related NER was not significantly affected by FCSEMS diameter. Further studies are needed to confirm the usefulness of 6-mm diameter FCSEMS for preoperative biliary drainagein patients with borderline resectable pancreatic cancer.

Multicenter study of the efficacy and safety of electrocautery-enhanced lumen-apposing metal stents for the internal drainage of pancreatic fluid collections

Pancreatic fluid collections (PFCs) including pancreatic pseudocyst (PP) and walled-off necrosis (WON) are complications after acute pancreatitis. We aimed to evaluate the efficacy and safety of endoscopic ultrasound (EUS)-guided lumen-apposing metal stent (LAMS) placement to manage PFCs. Between June 2019 and May 2023, patients with symptomatic PFCs who underwent EUS-guided electrocautery-enhanced LAMS drainage were enrolled retrospectively from eight tertiary centers in Taiwan. In total, 33 [14 (42.42%) PP and 19 (57.58%) WON] patients were enrolled. Gallstones (27.27%) and abdominal pain (72.73%) were the most common etiology and indication for drainage. The technical and clinical success rates were 100% and 96.97%, respectively, and the mean procedure time was 30.55 (± 16.17) min. Complications included one (3.03%) case of self-limited bleeding; there were no cases of mortality. Seven (21.21%) patients had recurrence. Patients with disconnected pancreatic duct syndrome (DPDS) had a higher recurrence rate than those without (71.43% vs. 38.46%, p = 0.05). After replacing LAMSs with transmural double-pigtail plastic stents (DPSs) in the DPDS patients, the DPS migration rate was higher in the patients with recurrence (100% vs. 33.33%, p = 0.04). In conclusion, drainage of symptomatic PFCs with EUS-guided electrocautery-enhanced LAMS appears to be efficient and safe. Replacing LAMSs with DPSs in DPDS patients was associated with a lower recurrence rate.

Endoscopic stone surgery in patients having asymptomatic bacteriuria

Introduction. Endoscopic surgery for the treatment of urolithiasis is highly effective but is associated with the risk of infectious complications. Nevertheless, endoscopy is also associated with the risk of postoperative infectious complications, the primary risk factor being positive urine culture. Considering the possibility of detecting persistent asymptomatic bacteriuria (ASB) in this patients amid the shortfall of clear algorithms and schemes of ASB management before endoscopy, a comparative analysis of infectious complications in patients with sterile urine and persistent ASB undergoing endoscopic surgery for renal and ureteral stones is an urgent task.Оbjective. Analysis of the risk of infectious complications in patients undergoing endoscopic treatment of urinary stones, including those with preoperative evidence of asymptomatic bacteriuria.Materials & methods. We conducted a cohort, retrospective study of data from eligible patients who underwent endoscopic removal of renal and ureteral stones between January 2023 and July 2023. From the 449 patient records selected, 211 patients fulfilling the established inclusion and non-inclusion criteria were enrolled in further analyses. Antibacterial prophylaxis was administered a few hours before surgery for initial sterile urine culture, three days before surgery for clinically insignificant ASB, and seven days before surgery for clinically significant ASB, followed by repeat control urine culture and determination of antibacterial prophylaxis according to the proposed methodology.Results. A preoperative sterile urine culture was diagnosed in 152 patients (72.0%), while 59 patients 28% [22%; 34.5%] were found to have bacteriuria, of which 28 patients 13.3% [9%; 18.6%] had clinically significant bacteriuria at a titer of ≥ 105 CFU/mL. After antibiotic therapy, ASB persisted in six patients (22.0%). Accordingly, 37 patients 17.5% [12.79%; 23.4%] with clinically significant and insignificant ASB underwent endoscopic surgery. In the postoperative period, 54 patients (25.6%) had leukocytosis, 17 patients (8.1%) had hyperthermia, and 11 patients (5.2%) had fever accompanied by leukocytosis One patient (0.5%) had an elevated procalcitonin level, which may indicate a systemic inflammatory response. Logistic regression analysis revealed statistically significant associations between the probability of hyperthermia and bacteriuria. A positive urine culture increased the odds of hyperthermia 4.75-fold (OR = 4,75, 95% CI [1.222; 18.803], p = 0.023). Maximum stone size (p = 0.013), stone volume, and ureteral stent drainage (p = 0.006) were the factors influencing the development of leukocytosis. Moreover, the volume of the stone increases the odds of leukocytosis by 1.54 times (OR = 1.543, 95% CI [1.128; 2.158], p = 0.008) for a 1.0 cc enlargement.Conclusion. Our study shows that a positive urine culture is a significant risk factor for infectious complications after endoscopic surgery. Prolonged courses of antibiotic prophylaxis lasting seven and three days in patients having clinically significant and clinically insignificant ASB, respectively, seem adequate to minimize the risk of postoperative infectious complications.

Safety of biliary drainage with 6-mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY.

The 10-mm self-expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6-mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. This was a single-arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent-related adverse events, and the key secondary endpoint was the non-recurrent biliary obstruction (non-RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent-related adverse event rate was 3.1% (n=1, acute pancreatitis) (95% confidential interval, 0.00-16.2), which met the criteria to be considered safe. The overall non-RBO rate during the observation period (median 96days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). The 6-mm FCSEMS is an extremely safe metallic stent with a low stent-related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non-RBO rate. UMIN Clinical Trial Registry (UMIN-CTR 000041704).

Comparative outcome of single versus two double-pigtail stents for endoscopic drainage of pancreatic fluid collections with minimal necrosis: a retrospective analysis.

Endoscopic ultrasound (EUS)-guided cystogastrostomy is the treatment of choice for managing symptomatic pancreatic fluid collections (PFC). However, studies on the number of stents for optimal drainage of PFCs are limited. Hence, the present study was conducted to compare the outcome of single versus two double-pigtail stents for endoscopic drainage of PFCs. This is a single-center, retrospective analysis of patients undergoing endoscopic drainage of PFCs with minimal necrosis (pseudocyst or walled-off necrosis with <30% solid content) at a tertiary center in South India from October 2020 to October 2022. Post-procedure, patients were followed up for clinical improvement, and stents were removed after documentation of cyst size reduction on imaging. Sixty-three patients (82.5% males, median age: 34 years) fulfilling the selection criteria were included. For single stent placement (n = 47), stents of size 8.5 Fr or 10 Fr were used, while for placement of two stents (n = 16), 7 Fr stents were used. The technical success rate was 100%. Intraprocedural and early postprocedural adverse events (all mild to moderate) were comparable between the groups (17.0% with single stent vs. 25.0% with two stents, p = NS). Clinical success was achieved in 93.6% of patients, with no difference between both groups. Three patients in the single stent group required additional procedures. All patients underwent successful stent removal after a median follow-up of 14 weeks. A single pigtail stent of 8.5 Fr or 10 Fr size for EUSguided cystogastrostomy provides efficacy and safety similar to that of two stents.

Safety and efficacy of early versus late removal of LAMS for pancreatic fluid collections.

Background and study aims Optimal timing for removal of lumen-apposing metal stents (LAMS) for effective drainage of pancreatic fluid collections (PFC) while minimizing adverse events (AE) is unknown. Outcomes of early (≤ 4 weeks) or delayed (> 4 weeks) LAMS removal on both clinical efficacy and the incidence of AE were assessed. Patients and methods This was a retrospective analysis of a prospectively maintained registry of PFC drainage between November 2016 and September 2021. Clinical success was defined as a 75% decrease in fluid collection volume with no need for reintervention at 6 months. AE were defined using the American Society for Gastrointestinal Endoscopy lexicon. Multiple logistic regression analysis was performed to determine variables associated with clinical success and AE. Results A total of 108 consecutive PFCs were included. LAMS deployment was technically successful in 103 of 108 cases (95.4%). Failure was associated with collection diameter ≤ 4 cm (odds ratio [OR] 24.0, P = 0.005) and presence of more than 50% necrotic material (OR 20.1, P = 0.01). Stents were left in place for a median of 48 days. Patients with early stent removal (< 4 weeks) had clinical success in 70.0% of cases, which was significantly less than in the group with delayed stent removal (96.4%, P = 0.03). On multiple regression analysis, clinical failure was associated with early stent removal (OR 25.5, P = 0.003). AEs occurred in 8.7% of cases (9/103). There were no predictors of AE. Notably, delayed stent removal did not predict the occurrence of AE. Conclusions Early LAMS removal (< 4 weeks) did not prevent AEs but did lead to increased clinical failure.

A novel lumen-apposing metal stent for endoscopic drainage of symptomatic pancreatic fluid collections: a retrospective study.

Previous studies showed that lumen-apposing metal stent (LAMS) provides a feasible route to perform direct endoscopic necrosectomy. However, the high risk of bleeding and migration induced by the placement of LAMS attracted attention. The aim of this study was to evaluate the safety and effectiveness of a novel LAMS. In this retrospective study, we enrolled patients with symptomatic pancreatic fluid collections (PFCs) to perform EUS-guided drainage with a LAMS in our hospital. Evaluation variables included technical success rate, clinical success rate, and adverse events. Thirty-two patients with a mean age of 41.38 ± 10.72 years (53.1% males) were included in our study, and the mean size of PFC was 10.06 ± 3.03 cm. Technical success rate and clinical success rate reached 96.9% and 93.8%, respectively. Stent migration occurred in 1 patient (3.1%), and no stent-induced bleeding occurred. The outcomes of using LAMS in 10 patients with pancreatic pseudocyst and 22 patients with walled-off necrosis were comparable. Compared with pancreatic pseudocyst, walled-off necrosis needed more direct endoscopic necrosectomy times to achieve resolution (P = 0.024). Our study showed that the novel LAMS is effective and safe for endoscopic drainage of PFCs with a relatively low rate of adverse events. Further large-scale multicenter studies are needed to confirm the present findings.