Endoscopic outcomes using a novel through-the-scope tack and suture system for gastrointestinal defect closure: a systematic review and meta-analysis.

BACKGROUND: Closure of gastrointestinal defects can reduce postprocedural adverse events. Over-the-scope clips and an over-the-scope suturing system are widely available, yet their use may be limited by defect size, location, operator skill level, and need to reinsert the endoscope with the device attached. The introduction of a through-the-scope helix tack suture system (TTSS) allows for closure of large irregular defects using a gastroscope or colonoscope, without the need for endoscope withdrawal. Since its approval 3 years ago, only a handful of studies have explored outcomes using this novel device. METHODS: Multiple databases were searched for studies looking at TTSS closure from inception until August 2023. The primary outcomes were the success of TTSS alone and TTSS with clips for complete defect closure. Secondary outcomes included complete closure based on procedure type (endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD]) and adverse events. RESULTS: Eight studies met the inclusion criteria (449 patients, mean defect size 34.3 mm). Complete defect closure rates for TTSS alone and TTSS with adjunctive clips were 77.2% (95%CI 66.4-85.3; I2=79%) and 95.2% (95%CI 90.3-97.7; I2=42.5%), respectively. Complete defect closure rates for EMR and ESD were 99.2% (95%CI 94.3-99.9; I2 = 0%) and 92.1% (95%CI 85-96; I2=0%), respectively. The adverse event rate was 5.4% (95%CI 2.7-10.3; I2=55%). CONCLUSION: TTSS is a novel device for closure of postprocedural defects, with relatively high technical and clinical success rates. Comparative studies of closure devices are needed.

EUS-guided gastroenterostomy using direct needle-puncture technique.

Background and Aims: EUS-guided gastroenterostomy (EUS-GE) is effective in relieving gastric outlet obstruction. Several techniques used to create EUS-GEs have been described. However, these techniques are dependent on passing a guidewire beyond the obstruction. We describe a direct needle-puncture technique that allows for successful EUS-GE creation without a guidewire. Methods: The direct antegrade EUS-GE method often involves passing a guidewire and tube beyond the obstruction to distend the small bowel. An oblique echoendoscope is then positioned in the stomach to locate the distended small bowel. An electrocautery-enhanced lumen-apposing metal stent (LAMS) is used to create the anastomosis. However, in cases when neither endoscope nor guidewire can be passed across the obstruction, the direct needle-puncture technique can be used. With the oblique echoendoscope positioned in the stomach, a collapsed loop of small bowel is located adjacent to the gastric wall. A 19-gauge needle is used to puncture the gastric and small bowel wall. The small bowel is distended with a mixture of saline, methylene blue, and contrast via a standard water pump connected to the needle. An antispasmodic is administered, and an electrocautery-enhanced LAMS is then introduced into the working channel to create a gastroenterostomy using the freehand method. Results: The direct needle-puncture technique was performed in 4 patients for these indications: postsurgical inflammation causing gastric outlet obstruction (case 1), tumor infiltration causing gastric outlet obstruction (cases 2A and 2B), and pancreaticobiliary limb access in a duodenal switch (case 3). The video shows the technique performed in a patient with postsurgical inflammation and a patient with duodenal tumor infiltration. Conclusions: The direct needle-puncture technique is useful for performing gastroenterostomy when the guidewire cannot be passed beyond the obstruction. It can also be used to gain access to a targeted bowel limb in altered anatomy for diagnostic and therapeutic purposes.

International Consensus Recommendations for Safe Use of LAMS for On- and Off-Label Indications Using a Modified Delphi Process.

INTRODUCTION: The study aimed to develop international consensus recommendations on the safe use of lumen-apposing metal stents (LAMSs) for on- and off-label indications. METHODS: Based on the available literature, statements were formulated and grouped into the following categories: general safety measures, peripancreatic fluid collections, endoscopic ultrasound (EUS)-biliary drainage, EUS-gallbladder drainage, EUS-gastroenterostomy, and gastric access temporary for endoscopy. The evidence level of each statement was determined using the Grading of Recommendations Assessment, Development, and Evaluation methodology.International LAMS experts were invited to participate in a modified Delphi process. When no 80% consensus was reached, the statement was modified based on expert feedback. Statements were rejected if no consensus was reached after the third Delphi round. RESULTS: Fifty-six (93.3%) of 60 formulated statements were accepted, of which 35 (58.3%) in the first round. Consensus was reached on the optimal learning path, preprocedural imaging, the need for airway protection and essential safety measures during the procedure, such as the use of Doppler, and measurement of the distance between the gastrointestinal lumen and the target structure. Specific consensus recommendations were generated for the different LAMS indications, covering, among others, careful patient selection, the preferred size of the LAMS, the need for antibiotics, the preferred anatomic location of the LAMS, the need for coaxial pigtail placement, and the appropriate management of LAMS-related adverse events. DISCUSSION: Through a modified international Delphi process, we developed general and indication-specific experience- and evidence-based recommendations on the safe use of LAMS.

Large Single-center Experience with Long-term Outcomes of EUS-guided Transmural Gallbladder Drainage.

GOALS: To describe the long-term outcomes of patients after EUS-guided gallbladder drainage (EUS-GBD), including those who underwent standardized stent exchanges for permanent plastic stents. BACKGROUND: EUS-GBD has become one of the first-line alternatives for gallbladder decompression, with outcomes and safety profiles comparable to that of percutaneous gallbladder drainage. However, the long-term outcomes of EUS-GBD are not well-described. We report our single-center experience of a large cohort who underwent EUS-GBD. STUDY: Patients who underwent EUS-GBD from August 2014 to December 2022 were included in the study. Patient demographics, comorbidities, and procedure details were recorded. Patients were followed until complete stent removal, end of study period, or death. Short and long-term outcomes include technical and clinical success, stent patency, recurrent cholecystitis, cholecystectomy, and death. RESULTS: During the study period, 128 patients were included. One hundred and one patients had benign indications for EUS-GBD, including cholecystitis and choledocholithiasis. Of those with malignant indications, 23 of 27 had distal malignant biliary obstruction. Technical and clinical successes were 95.3% and 95.1%, respectively. Stents were exchanged for 2 permanent double pigtail plastic stents in 43.0%. The mean stent patency was 421 days (488 d among those still alive) without any recurrent cholecystitis. CONCLUSION: EUS-GBD demonstrates prolonged stent patency and minimal long-term adverse events, particularly among patients who underwent stent exchanges for permanent plastic stents. EUS-GBD is also promising for patients presenting with choledocholithiasis and biliary colic who are not surgical candidates.

Cholangioscopic recanalization of a completely obstructed anastomotic biliary stricture after liver transplant.

Video 1A 51-year-old woman underwent orthotopic liver transplant with duct-to-duct anastomosis for primary biliary cholangitis 8 months prior to presentation. Two months postoperatively, she presented with clinical biliary pancreatitis. An MRCP performed on admission demonstrates dilated donor biliary tree and a severe stricture at the anastomosis. An index ERCP shows an indwelling surgical biliary "stent" exiting the duodenal papillae and anastomotic stricture. The surgical stent was removed, a sphincterotomy was performed, and there was an inability to traverse the anastomotic stricture. A representative cholangiogram shown here demonstrates the presence of a severe stricture completely obstructing the biliary tree. ERCP was done the next day, placing a 10-mm × 8-cm fully covered metal stent throughout the anastomosis. Three months later, the stent was removed because there was recurrent stricture at the site of anastomosis. Four months after stent removal, the patient again presented with clinical and laboratory obstructive biliary disease. A follow-up MRCP showed a severe anastomotic biliary stricture with an upstream stone. Several attempts were made to pass ERCP antegrade through the stenosis. However, they were unsuccessful. The rate-limiting step for successful recanalization was guidewire passage across the stricture. In this case, there was complete obliteration of the lumen by fibrosis. Efforts to pass 0.025-inch and 0.035-inch angled hydrophilic guidewires were unsuccessful. Recurrent stricturing was believed to be because of ischemia or inadequate recanalization. Our approach was to attempt antegrade recanalization and biliary decompression through an EUS-guided hepatogastrostomy. However, antegrade recanalization was unsuccessful and led to retrograde cholangioscopy using a single-use endoscope (SpyScope DS-2; Boston Scientific, Marlborough, Mass, USA) 4 weeks later. This video shows the cholangioscopic recanalization process. There was no passage of contrast antegrade or retrograde. During the cholangioscopy, there was no visible lumen. The area of suspected anastomosis based on the pearly white appearance of scar tissue was approached using mini-forceps (SpyBite; Boston Scientific) and a bite-on-bite approach to re-establish a lumen for stent placement. We used the pearly scar tissue as a guide to ensure the correct site for recanalization. We felt comfortable doing this because a hepatogastrostomy and sphincterotomy were thought to be protective against any bile leak if tunneling had dissected out of the duct. Moreover, contrast injection was used periodically to monitor progression into the duct. Eventually, the forceps were advanced into the proximal biliary tree under cholangioscopic direction, re-establishing a lumen. Bile is seen flowing through the identified lumen. While a rendezvous approach with antegrade transillumination and a percutaneous SpyScope DS-2 might be safer for recanalization of complete obstruction, the process would require multiple admissions and procedures for percutaneous access and fistula maturation. This might increase morbidity for this patient with no difference in outcome. We propose that cholangioscopic recanalization along with protection from bile leakage would be a reasonable approach in this case and similar cases with altered anatomy, hepatogastrostomy in place, or unavailability for follow-up or multiple procedures. This is an intraoperative radiographic representation. On the left, the cholangiogram is seen in place and the mini-forceps are passing through it into the proximal biliary tree. On the right, passage of the guidewire with balloon dilation of the stricture is shown. The stone previously seen on MRCP passed spontaneously. A follow-up cholangiogram showed luminal patency. A 10-mm × 10-cm fully covered metal stent (Viabil; W.L. Gore, Flagstaff, Ariz, USA) was placed across anastomosis.

Endoscopic Management of Gallbladder Disease.

PURPOSE OF REVIEW: Diseases of the gallbladder can be increasingly managed through endoscopic interventions, either serving as an alternative to or obviating the need for cholecystectomy. In this review, we aim to review the most recent data on endoscopic management of the most common gallbladder diseases. RECENT FINDINGS: The development of lumen-opposing metal stents (LAMS) marked a major shift in gallbladder management, with transmural techniques now well studied for management of cholecystitis. Endoscopic ultrasound (EUS) is also a well-developed technique for gallbladder imaging, comparable or superior to transabdominal ultrasound. Novel techniques with LAMS for gallbladder lesion/polyp resection and treatment of non-cholecystitis gallbladder diseases mark important milestones in gallbladder preservation and increasingly less invasive management of diseases of the gallbladder. There are multiple interventional endoscopic techniques that can be used to manage common gallbladder diseases including cholecystitis, cholelithiasis, gallbladder lesions/polyps, and gallbladder cancer. Ongoing development of novel therapeutic techniques holds promise for additional minimally invasive techniques in the future.

Therapeutic Endoscopic Ultrasound: Current Indications and Future Perspectives.

The transcendence of endoscopic ultrasound (EUS) from diagnostic to therapeutic tool has revolutionized management options in the field of gastroenterology. Through EUS-guided methods, pancreaticobiliary obstruction can now be utilized as an alternative to surgical and percutaneous approaches. This modality also allows for gallbladder drainage in patients who are not ideal operative candidates. By utilizing its unique imaging capabilities, EUS also allows for drainage access points in cases of gastric outlet obstruction as well as windows to ablate pancreatic cystic lesions. As technical progress continues to evolve, interventional gastroenterology continues to push the envelope of minimally invasive therapeutic procedures in a multidisciplinary setting. In this comprehensive review, we set out to describe current indications and innovations through EUS.

A transformação da ecoendoscopia (EUS) de um método de diagnóstico a ferramenta terapêutica revolucionou a abordagem na gastroenterologia. As terapêuticas guiadas por EUS, nomeadamente as obstruções pancreatobiliares, constituem agora alternativas às abordagens cirúrgicas e percutâneas. Esta modalidade terapêutica permite também a drenagem da vesícula biliar em doentes que não são candidatos cirúrgicos. Além disso, ao utilizar as suas capacidades únicas de imagem, a EUS permite a drenagem em casos de obstrução da saída gástrica, bem como realizar a ablação de lesões císticas pancreáticas. O crescente progresso da gastrenterologia permite o desenvolvimento de procedimentos terapêuticos minimamente invasivos num ambiente multidisciplinar. Nesta revisão, propusemos-nos a descrever as atuais indicações e inovações através da EUS.

Endoscopic Necrosectomy.

The management of walled-off necrosis has evolved substantially over the past 23 years since its first description. In this article, we review its history and the evidence supporting modern treatment, which is still subject to heterogeneity across centers and among endoscopists. This allows for creativity and customization of what can be an endoscopic marathon. Our typical practice is discussed with image and video guides aimed at improving procedure success.

Self-expandable metallic stent-induced esophagorespiratory fistulas in patients with advanced esophageal cancer.

BACKGROUND/AIMS: Self-expandable metallic stents (SEMSs) are widely adopted for the palliation of dysphagia in patients with malignant esophageal strictures. An important adverse event is the development of SEMS-induced esophagorespiratory fistulas (SEMS-ERFs). This study aimed to assess the risk factors related to the development of SEMS-ERF after SEMS placement in patients with esophageal cancer. METHODS: This retrospective study was performed at the Instituto do Cancer do Estado de São Paulo. All patients with malignant esophageal strictures who underwent esophageal SEMS placement between 2009 and 2019 were included in the study. RESULTS: Of the 335 patients, 37 (11.0%) developed SEMS-ERF, with a median time of 129 days after SEMS placement. Stent flare of 28 mm (hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.15-5.51; p=0.02) and post-stent chemotherapy (HR, 2.0; 95% CI, 1.01-4.00; p=0.05) were associated with an increased risk of developing SEMS-ERF, while lower-third tumors were a protective factor (HR, 0.5; 95% CI, 0.26-0.85; p=0.01). No difference was observed in overall survival. CONCLUSION: The incidence of SEMS-ERFs was 11%, with a median time of 129 days after SEMS placement. Post-stent chemotherapy and a 28 mm stent flare were associated with a higher risk of SEMS-ERF.

Management of biliary complications in liver transplant recipients using a fully covered self-expandable metal stent with antimigration features.

BACKGROUND: Following liver transplant (LT) with duct-to-duct anastomosis, biliary strictures and leaks are typically managed with endoscopic retrograde cholangiopancreatography (ERCP) and stenting. While multiple side-by-side plastic stents are typically used for management of anastomotic strictures, fully covered self-expandable metal stents (FCSEMS) can be used to decrease the number of ERCPs with longer periods of stent patency. The risk of migration can limit their use. FCSEMS with antimigration fins to manage benign biliary complications following LT may provide stricture resolution with limited adverse events (AEs). METHODS: Single center retrospective study of LT patients who required FCSEMS from 1/2014 to 4/2022. Primary outcomes included stricture resolution and recurrence. Secondary outcomes were stent migration, occlusion, removability, and number of ERCPs. RESULTS: Forty-three patients (mean age 55.5 years) with anastomotic strictures (N.=37), bile leaks (N.=4) or both (N.=2) were included. The median time from LT to FCSEMS placement was 125 days. Within one year of LT, 31 patients required intervention; early intervention at less than 30 and 90 days was needed in 7 and 19 patients, respectively. The median length of follow up was 816.5 days. Stricture resolution was seen in 35 patients (81%) after a median stent dwell time of 130.5 days; recurrence occurred in 8 patients. There were three instances of partial stent migration that did not require reintervention or interfere with removability. The mean number of ERCPs required was 2.5. CONCLUSIONS: The use of a FCSEMS with antimigration features yields effective stricture resolution with longer stent dwell times and fewer ERCPs.

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

Familial pancreatic cancer.

Pancreatic cancer (PC) carries a poor prognosis with an overall 5-year survival of less than 10%. Early diagnosis, though cumbersome, is essential to allow complete surgical resection. Therefore, primary and secondary prevention are critical to reduce the incidence and to potentially prevent mortality. Given a relatively low lifetime risk of developing PC, identification of high-risk individuals is crucial to allow identification of pre-malignant lesions and small, localized tumors. Although 85-90% of PC cases are sporadic, we could consider risk stratification for the 5-10% of patients with a family history and the 3-5% of cases due to inherited genetic syndromes. These high-risk populations should be considered for screening and surveillance of PC. MRI/MRCP and EUS are the preferred modalities, due to their high sensitivity in lesion detection. Surveillance should be personalized, considering genetics and family history, and assessment of risk factors that may increase cancer risk. Screening programs should be limited to tertiary referral center, with high-volumes and adequate facilities to manage these patients.

Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial.

OBJECTIVE: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). BACKGROUND: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. METHODS: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). RESULTS: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. CONCLUSIONS: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.