Management and outcomes in a consecutive series of patients with aero-digestive fistula at a tertiary gastro-esophageal surgery center.

Aerodigestive fistula (ADF) is defined as a pathological connection between the upper digestive tract and the airway. ADF is associated with high morbidity and mortality and management is often complex. A cohort study including all patients admitted with ADF 2004-2022 at a single tertiary esophageal surgery center was performed based on prospectively collected administrative data and retrospectively collected electronic patient chart data,. Patient demographics, performance status, comorbidity, fistula characteristics, management, and outcomes in terms of morbidity and mortality were assessed in patients with ADF of three distinct types: (i) tumor overgrowth-related, (ii) various benign etiologies, and (iii) post-esophagectomy. Sixty-one patients with ADF were included in the study, 33 (54.1%) tumor overgrowth-related, six (9.8%) benign and 22 (36.1%) post-esophagectomy. In the post-esophagectomy group 15 out of 22 (68.2%) patients were diagnosed with anastomotic leakage prior to ADF diagnosis. Self-expandable metallic stents (SEMS) were used for temporary fistula sealing in 59 out of 61 (96.7%) patients, of which most received stents in both the digestive tract and airway. Temporary fistula sealing with stents was successful enabling discharge from hospital in 47 out of 59 (79.7%) patients. Definitive ADF repair was performed in 16 (26.2%) patients, of which one (6.3%) died within 90-days and 15 could be discharged home with permanently sealed fistulas. ADF is a complex condition associated with high mortality, which often requires multiple advanced interventions. SEMS can be applied in the airway and simultaneously in the digestive tract to temporarily seal the ADF as bridge to definitive surgical repair.

Long-term outcomes of duckbill-type anti-reflux metal stents versus conventional covered metal stents in reinterventions after covered biliary metal stent dysfunction in unresectable pancreatic cancer.

BACKGROUND: The use of duckbill-type anti-reflux metal stents (DMS) in reinterventions after covered metal stent (CMS) dysfunction has been reported in patients with distal malignant biliary obstruction (MBO). However, the superiority of DMS over conventional CMS (c-CMS) has not been established. Therefore, we conducted this retrospective study to evaluate the long-term efficacy and safety of DMS as a second stent in comparison with c-CMS. METHODS: We investigated consecutive patients with distal MBO due to unresectable pancreatic cancer who underwent reintervention after dysfunction of initial biliary CMS at our institution. We compared causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates of DMS and c-CMS in this stenting. RESULTS: A total of 76 patients were included (DMS 41 and c-CMS 35). While overall RBO rates were similar between the two groups (46% vs. 63%, p = 0.172), RBO due to non-occlusion cholangitis tended to be less frequent in the DMS group than in the c-CMS group (2% vs. 14%, p = 0.089). Median TRBO was significantly longer in the DMS group (286 days vs. 112 days, p = 0.029). DMS was identified as the only significant risk factor for TRBO (hazard ratio, 0.52; p = 0.044). Overall AE rates were significantly lower in the DMS group (2% vs. 23%, p = 0.010), with non-occlusion cholangitis being the most common AE in the c-CMS group. Endoscopic reintervention was successfully performed in all patients in both groups, despite failed stent removal in 15% of patients in DMS group. CONCLUSIONS: DMS was associated with a significantly longer TRBO and lower rate of AEs compared with c-CMS in reinterventions after initial CMS dysfunction. DMS may be preferable to c-CMS as a second stent after biliary CMS dysfunction.

Safety and feasibility of esophageal self- expandable metal stent placement without the aid of fluoroscopy.

Self-expandable metal stents (SEMSs) are used for the management of certain esophageal conditions such as strictures, perforations, and fistulae. These can be placed using fluoroscopic control, endoscopic control, or a combination of both. We evaluated our institutional experience of placing a SEMS using only endoscopy without the aid of fluoroscopy to determine safety and feasibility using this technique. A retrospective review was performed to identify all patients who underwent esophageal SEMS from January 2010 to June 2015. Placement of SEMS was accomplished under direct endoscopic visualization without the aid of fluoroscopy. Esophageal lesion was initially identified during endoscopy and a fully covered SEMS was passed over the guide wire and deployed under direct vision. Misplacement of the SEMS during the procedure that required replacement with another new SEMS was considered as a failed procedure. Other periprocedural complications caused by placement of SEMS were noted. A total of 172 patients underwent 280 procedures for SEMS placement. Mean age was 66 years. The most common indication for SEMS placement was stricture in 248 (88%) procedures. Periprocedure SEMS misplacement occurred in 12 (4%) patients. However, only 8 (3%) patients needed to have a new SEMS placed during the same procedure. A total of 64 (23%) patients had migration of SEMS. There were no other periprocedure complications leading to adverse events. Self-expandable metal stent can be placed accurately and safely under direct endoscopic visualization without the aid of fluoroscopy.

Novel flower-type covered metal stent to prevent cholecystitis: experimental study in a pig model.

BACKGROUND: Covered self-expandable metal stent (CSEMS) has the risk of obstruction of the cystic duct, and the main and branch pancreatic ducts due to strong radial force and covering material, which results in cholecystitis and pancreatitis. A flower-type covered self-expandable metal stent (F-CSEMS) having a five-petal-shaped design with side grooves was constructed to prevent the obstruction of the cystic duct orifice. This study investigated the value of the F-CSEMS in protection for cholecystitis in a pig model. METHODS: Fourteen pigs randomly underwent endoscopic placement of either F-CSEMS or conventional CSEMS (C-CSEMS). The stent was placed across the cystic duct orifice to impede bile drainage from the gallbladder. Drainage was checked at 24, 48, 120 and 168 h after implantation. Blood was collected at baseline, on days 2 and 7 following implantation. The animals were killed for histologic evaluation on day 7. RESULTS: All stents were successfully inserted into bile duct without any procedure-related complications. At 48 h, the rate of contrast drainage from the gallbladder was higher in the F-CSEMS group than the C-CSEMS group without significant difference (71.4 vs. 28.6% p = 0.28). C-CSEMS was associated with higher levels of C-reactive protein (35.2 vs. 20.5 µg/dl, p = 0.03) and histologic inflammatory scores of gallbladder (score 4 vs. 2; p = 0.03). CONCLUSION: The F-CSEMS appears safe and helpful to prevent cholecystitis without disturbance of bile flow in a pig model.

Clinical remission following endoscopic placement of retrievable, fully covered metal stents in patients with esophageal achalasia.

Metal stents may represent an alternative therapy in the treatment of achalasia. We therefore evaluated the effectiveness of retrievable, fully covered metal stents in patients with achalasia. Fifty-nine patients with achalasia were treated with retrievable, fully covered metal stents. Symptoms using a global symptom score (0-10), lower esophageal sphincter (LES) resting pressure, LES relaxation, and simultaneous contraction of the esophagus were analyzed before and 1 week and 1 month after intervention. Complications and treatment outcomes were followed up at 6, 12, 18, and 24 months postoperatively. Stent placement was successful, and clinical symptoms resolved (P < 0.01) in all patients. Regurgitation, dysphagia and chest pain improved significantly (all P < 0.01). Therapy improved LES resting pressure (51.4 ± 9.7 mmHg pretherapy vs. 20.9 ± 8.1 mmHg post-therapy), LES relaxation (58.1 ± 17.1% pretherapy vs. 84.5 ± 18.9% post-therapy), and simultaneous contraction of the esophagus (36.1 ± 8.6% pretherapy vs. 69.4 ± 23.1% post-therapy) 1 month after stent placement (all P < 0.01). The cumulative clinical remission rates 6, 12, 18, 24, 30, and 36 months after stent removal were 90.9%, 81.8%, 76.4%, 69.1%, 65.5%, and 49.1%, respectively. All patients tolerated stent placement. Twelve patients (25.5%) complained of substernal pain and five (10.6%) had substernal burning. Stents migrated in four patients (8.5%). Insertion of retrievable, fully covered metal stents is an effective and safe treatment in patients with achalasia.

Endoscopic ultrasonography-guided cholecystogastrostomy in patients with unresectable pancreatic cancer using anti-migratory metal stents: a new approach.

Cholecystectomy is contraindicated in patients with comorbidities or unresectable cancer. Percutaneous transhepatic gallbladder drainage (PTGBD) is typically offered with response rates ranging from 56% to 100%, but has several risks such as bleeding, pneumothorax, pneumoperitoneum, bile leak, and/or catheter migration. Endoscopic transpapillary gallbladder drainage (ETGD) and endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD) are alternative endoscopic modalities that have a technical feasibility, efficacy and safety profile comparable with PTGBD. In this report, we present the first case series of transgastric EUS-GBD with placement of a fully covered self-expandable metal stent with anti-migratory fins. In three pancreatic cancer cases with acute cholecystitis when ETGD was unsuccessful, there were no bile leaks or procedurally related complications. There were no acute cholecystitis recurrences. In conclusion, EUS-GBD is a promising, minimally invasive treatment for acute cholecystitis. Additional comparative studies are needed to validate the benefit of this technique.

Stent Deployment Without Tract Dilation in Endoscopic Ultrasound-Guided Hepaticogastrostomy Using a Novel Partially Covered Metal Stent With a Super-Slim Stent Delivery System: A Case Report.

Endoscopic ultrasound-guided hepaticogastrostomy is performed when transpapillary biliary drainage using endoscopic retrograde cholangiopancreatography is difficult due to surgically altered anatomy, an inaccessible papilla, or difficult biliary cannulation. This procedure consists of puncturing the intrahepatic bile duct from the stomach, inserting a guidewire into the bile duct, dilating the puncture tract, and placing a stent. Recently, a novel partially covered self-expandable metal stent with a super-slim stent delivery system of 5.9 Fr has become available. With this stent, endoscopic ultrasound-guided hepaticogastrostomy can be performed without using a dilator to expand the puncture tract. Herein, we describe a technique for dilator-free stent deployment for endoscopic ultrasound-guided hepaticogastrostomy using this novel stent. We performed an endoscopic ultrasound-guided hepaticogastrostomy with this stent in a 65-year-old patient with obstructive jaundice due to pancreatic head cancer without adverse events and with satisfactory improvement in jaundice. This procedure is expected to reduce bile leakage into the abdominal cavity and shorten the procedure time.

The efficacy and safety of a duckbill-type anti-reflux metal stent as the initial metal stent for distal malignant biliary obstruction in unresectable pancreatic cancer.

Background: The usefulness of duckbill-type anti-reflux metal stent (DMS) in self-expandable metal stent-naïve pancreatic cancer (PC) patients has not been well-studied. This study aimed to evaluate the efficacy and safety of DMS in such patients. Methods: We analyzed consecutive patients with unresectable PC who received a covered metal stent (CMS) as the initial self-expandable metal stent at our institution. Technical success, functional success, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates were compared between DMS and conventional CMS (c-CMS). Results: A total of 69 patients were included (DMS: 28, c-CMS: 41). Technical success, functional success, and AEs were similar between groups. Tumor ingrowth was more common in the DMS group (18% vs. 0%, p = 0.009), while non-occlusion cholangitis tended to be more common in the c-CMS group (0% vs. 15%, p = 0.074). Median time to RBO was similar between groups (276 vs. 273 days, p = 0.915). The anti-reflux valve of DMS was found torn in 56% of patients. Endoscopic reintervention was successful in all cases, despite failed stent removal in 88% of patients in the DMS group. Conclusions: DMS was not associated with longer time to RBO compared to c-CMS in self-expandable metal stent-naïve patients.

Intraductal fully covered self-expanding metal stents in the management of post-liver transplant anastomotic strictures: a UK wide experience.

Background: Fully covered intraductal self-expanding metal stents (IDSEMS) have been well described in the management of post-liver transplant (LT) anastomotic strictures (ASs). Their antimigration waists and intraductal nature make them suited for deployment across the biliary anastomosis. Objectives: We conducted a multicentre study to analyse their use and efficacy in the management of AS. Design: This was a retrospective, multicentre observational study across nine tertiary centres in the United Kingdom. Methods: Consecutive patients who underwent endoscopic retrograde cholangiopancreatography with IDSEMS insertion were analysed retrospectively. Recorded variables included patient demographics, procedural characteristics, response to therapy and follow-up data. Results: In all, 162 patients (100 males, 62%) underwent 176 episodes of IDSEMS insertion for AS. Aetiology of liver disease in this cohort included hepatocellular carcinoma (n = 35, 22%), followed by alcohol-related liver disease (n = 29, 18%), non-alcoholic steatohepatitis (n = 20, 12%), primary biliary cholangitis (n = 15, 9%), acute liver failure (n = 13, 8%), viral hepatitis (n = 13, 8%) and autoimmune hepatitis (n = 12, 7%). Early AS occurred in 25 (15%) cases, delayed in 32 (20%) cases and late in 95 (59%) cases. Age at transplant was 54 years (range, 12-74), and stent duration was 15 weeks (range, 3 days-78 weeks). In total, 131 (81%) had complete resolution of stricture at endoscopic re-evaluation. Stricture recurrence was observed in 13 (10%) cases, with a median of 19 weeks (range, 4-88 weeks) after stent removal. At removal, there were 21 (12%) adverse events, 5 (3%) episodes of cholangitis and 2 (1%) of pancreatitis. In 11 (6%) cases, the removal wires unravelled, and 3 (2%) stents migrated. All were removed endoscopically. Conclusion: IDSEMS appears to be safe and highly efficacious in the management of post-LT AS, with low rates of AS recurrence.

Covered metallic stent placement for biliary drainage could be promising in the coming era of neoadjuvant chemo-radiation therapy for all pancreatic cancer.

BACKGROUND/PURPOSE: The role of endoscopic preoperative biliary drainage for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. We sought to validate a suitable stent for biliary drainage in patients with pancreatic cancer undergoing neoadjuvant chemotherapy (NAC)/neoadjuvant chemoradiotherapy (NAC-RT). METHODS: We evaluated patients who received preoperative neoadjuvant therapy for pancreatic head cancer between January 2013 and December 2019. A covered metal (CMS) or plastic stent (PS) was inserted in symptomatic patients for biliary drainage. Recurrent biliary obstruction (RBO), success rate of endoscopic drainage, adverse events, and surgical outcomes were compared between the CMS and PS groups. RESULTS: Occurrence rate of RBO was significantly higher with PS (97%) vs CMS (15%, P < .001), and time to RBO was significantly longer with CMS vs PS (not reached vs 40.5 days, P < .001). Delayed schedule associated with RBO for neoadjuvant chemotherapy was significantly lower in CMS vs PS (14% vs 50%, P < .05). There was no difference in postoperative bleeding, operation time, complications, and rate of a microscopically margin-negative resection between groups. CONCLUSIONS: Use of CMS during NAC/NAC-RT allows for safe chemotherapy without causing cholangitis or biliary obstruction and for surgery to be performed.

Stepwise Algorithmic Approach to Endoscopic Removal of Biliary Partially Covered and Uncovered Self-Expanding Metal Stents.

Self-expanding metal stents play a crucial role in the management of patients with biliary obstruction. Endoscopic extraction of uncovered metal stents (UCMSs) and partially covered metal stents (PCMSs) could be challenging because of tissue ingrowth. No standardized technique can guarantee universal success. We present our technique and experience of endoscopic extraction of biliary stents in two patients with a UCMS and three patients with a PCMS. Three of the five patients had a previous failed attempt of stent extraction at an outside hospital. Overall, our composite success rate was 80% (4/5). The individual success rate was 100% (3/3) for PCMSs and 50% (1/2) for UCMSs. The stent-in-stent technique, in which a fully covered metal stent is placed through an existing UCMS/PCMS, was used in 60% (3/5) of the cases, with a success rate of 66.7% (2/3). We share our algorithmic approach to each case, with detailed emphasis on the technical aspects of the procedure.

Fully-covered metal stent for the treatment of post-percutaneous transhepatic biliary drainage (PTBD) obstruction due to a blood clot in the common bile duct: a case report.

AIM: This study aimed to report a case of a fully-covered metal stent for the treatment of post-Percutaneous Transhepatic Biliary Drainage (PTBD) obstruction caused by a blood clot in the common bile duct (CBD). CASE PRESENTATION: The case involved a 75-year-old man who had a history of recurring upper abdominal pain and jaundice. The result of an abdominal computerized tomography showed a stricture in the CBD. After PTBD, bleeding in the tube of PTBD was noted. The bleeding sites were detected using superselective hepatic arteriography. After the bleeding was stopped, Endoscopic Retrograde Cholangiopancreatography (ERCP) was performed to insert a fully-covered metal stent to extract the blood clot. Five months later, He was performed whipple procedure successfully and the pathology shows adenocarcinoma (cholangicarcinoma). This was the first case reported in China. CONCLUSIONS: The complications related to post-PTBD obstruction, which was caused by a blood clot in the CBD, might lead to serious health issues or even death. The blood clot could be diagnosed according to laboratory and clinical data, particularly imaging. Digital subtraction angiography (DSA) and ERCP were necessary and effective for the patient in the present case. Successfully placement of a fully-covered stent could relieve jaundice. The residual thrombus was easily extracted through the stent. This was important for the preparation of the coming procedure.

Effective Endoscopic Closure of Cholecysto-duodenal and Transverse Colon Fistulas Due to Squamous Cell Carcinoma of the Gallbladder Using Polyglycolic Acid Sheets and a Covered Metal Stent.

An 81-year-old woman presented with abdominal distension and right hypochondrial pain. Abdominal contrast computed tomography and magnetic resonance imaging revealed an 11-cm gallbladder tumor. The patient was diagnosed with squamous cell carcinoma of the gallbladder by endoscopic ultrasound-guided fine-needle aspiration from the gastric antrum. Thereafter, the gallbladder tumor enlarged, and cholecysto-duodenal and transverse colon fistulas were formed. A covered metal stent was placed on the transverse colon, and polyglycolic acid sheets were injected into the duodenum to close the fistulas endoscopically. Endoscopic closure is less invasive than surgery and considered effective for patients with poor general health conditions.

Progress of esophageal stricture prevention after endoscopic submucosal dissection by regenerative medicine and tissue engineering.

Endoscopic submucosal dissection (ESD) has been widely accepted as an effective treatment for early esophageal cancer. However, post-ESD esophageal stricture remains a thorny issue. We herein review many strategies for preventing post-ESD esophageal stricture, as well as discuss their strengths and weaknesses. These strategies include pharmacological prophylaxis, esophageal stent and tissue engineering and regenerative medicine treatment. In this review, we summarize these studies and discuss the underlying progress and future directions of tissue engineering and regenerative medicine treatment.

Endoscopic ultrasound-guided hepaticogastrostomy using a partially covered metal stent in patients with malignant biliary obstruction after failed Endoscopic retrograde cholangiopancreatography.

BACKGROUND AND AIM: The advent of endoscopic ultrasound-guided biliary drainage (EUS-BD) has provided an inimitable alternative for gaining biliary access in patients who fail conventional endoscopic drainage. The antimigratory features of the partially covered metal stent (PCMS), namely, the flange head and uncovered portion of the stent, makes it a valuable option in patients undergoing EUS-guided hepaticogastrostomy (EUS-HGS). The aim of the study is to evaluate the clinical outcome of EUS-BD via the hepaticogastrostomy approach using PCMS in patients with malignant biliary obstruction after failed ERCP. METHODS: This is a single-center retrospective observational study of patients with malignant biliary obstruction undergoing EUS-HGS after failed ERCP between January 2018 and May 2019. The end-point of the study was to assess the technical and clinical success rate, as well as the stent- and procedure-related complications. RESULTS: There were 20 subjects in this study. The average age was 71.8 ± 7.6 years. Most patients were male, 16 (80%). Inaccessible papillae was the most common indication for this procedure, 16 (80%). Technical success was achieved in all patients. The average procedural time was 39.9 ± 1.3 min. Mean preprocedural bilirubin levels were 348.6 ± 28.8 and subsequently decreased to 108.94 ± 37.1 µmol/L at 2 weeks postprocedure. The clinical success rate was 95% (19/20), with one patient requiring percutaneous transhepatic biliary drainage (PTBD). There were no stent- or procedure-related complications reported in this study. CONCLUSION: EUS-HGS with PCMS is a feasible, effective, and safe alternative for biliary decompression in patients with failed endoscopic retrograde cholangiopancreatography (ERCP).

Optimization of biliary drainage in inoperable distal malignant strictures.

BACKGROUND: Given most patients with distal malignant biliary obstruction present in the non-resectable stage, palliative endoscopic biliary drainage with fully covered metal stent (FCMS) or uncovered metal stent (UCMS) is the only available measure to improve patients' quality of life. Half covered metal stent (HCMS) has been recently introduced commercially. The adverse effects and stent function between FCMS and UCMS have been extensively discussed. AIM: To study the duration of stent patency of HCMS and compare it with FCMS and UCMS to optimize biliary drainage in inoperable patients with distal malignant obstruction. Secondary aims in our study included evaluation of patients' survival and the rates of adverse events for each type of stent. METHODS: We studied 210 patients and randomized them into three equal groups; HCMS, FCMS and UCMS were inserted endoscopically. RESULTS: Stent occlusion occurred in (18.6%, 17.1% and 15.7% in HCMS, FCMS and UCMS groups, respectively, P = 0.9). Stent migration occurred only in patients with FCMS (8.6% of patients). Cholangitis and cholecystitis occurred in 11.4% and 5.7% of patients, respectively, in FCMS. Tumor growth occurred only in 10 cases among patients with UCMS after a median of 140 d, sludge occurred in nine, seven and one patients in HCMS, FCMS and UCMS, respectively (P = 0.04). CONCLUSION: Given the prolonged stent functioning time, the use of HCMS is preferred over the use of UCMS and FCMS for optimizing biliary drainage in patients with distal malignant biliary obstruction.

Prospective multicenter study of primary EUS-guided choledochoduodenostomy using a covered metal stent.

BACKGROUND AND OBJECTIVES: EUS-guided biliary drainage (EUS-BD) is increasingly reported as a salvage technique after failed endoscopic retrograde cholangiopancreatography, but it is still controversial whether EUS-BD can replace transpapillary biliary stenting. Therefore, we conducted this multicenter, prospective study of EUS-guided choledochoduodenostomy (EUS-CDS) using a covered metallic stent (CMS) as primary biliary drainage for unresectable distal malignant biliary obstruction (MBO). METHODS: Patients with unresectable distal MBO without any prior drainage are enrolled. Primary endpoint is a technical success and secondary endpoints are adverse events, functional success, and recurrent biliary obstruction (RBO) of EUS-CDS. Clinical outcomes were compared between EUS-CDS and transpapillary stenting as a control. RESULTS: A total of 34 patients were enrolled in 10 Japanese institutions. The cause of MBO was pancreatic cancer in 28 patients. Median tumor size and common bile duct diameter were 31 and 13 mm, respectively. Technical success rate was 97% with a median procedure time of 25 min and functional success rate was 100%. The rate of RBO was 29% and the causes of RBO were nontumor related: Migration in 18%, sludge/food impaction in 9%, and stent impaction to the duodenal wall in 3%. Other adverse events were abdominal pain in 6% and cholecystitis in 9%. A median cumulative time to RBO was 11.3 months. The rate of RBO and cumulative time to RBO of EUS-CDS were comparable to those of transpapillary stenting (36% and 9.1 months, respectively). CONCLUSION: EUS-CDS using a CMS as primary biliary drainage was technically feasible and its safety appeared comparable to transpapillary stenting.

Management of Benign and Malignant Pancreatic Duct Strictures.

The diagnosis and management of pancreatic strictures, whether malignant or benign, remain challenging. The last 2 decades have seen dramatic progress in terms of both advanced imaging and endoscopic therapy. While plastic stents remain the cornerstone of the treatment of benign strictures, the advent of fully covered metal stents has initiated a new wave of interest in calibrating the pancreatic duct with fewer sessions. In malignant disease, palliation remains the priority and further data are necessary before offering systematic pancreatic stenting.