Long-term outcomes of standardized colonic stenting using WallFlex as a bridge to surgery: Multicenter prospective cohort study.

OBJECTIVES: The oncological outcomes, especially high recurrence rate, of bridge-to-surgery (BTS) self-expandable metallic stent (SEMS) placement remain concerning, emphasizing the necessity of standardized SEMS placement. However, its impact on long-term BTS outcomes is unknown. We investigated the long-term outcomes of BTS colonic stenting using standardized SEMS placement. METHODS: This prospective, multicenter cohort study conducted at 46 hospitals in Japan (March 2012 to October 2013) included consecutive patients with stage II and III obstructive colorectal cancer managed with BTS SEMS placement. The SEMS placement technique was standardized by information dissemination among the participating hospitals. The primary outcome was overall survival (OS) after SEMS placement, and the secondary outcomes were relapse-free survival (RFS), recurrence, and short-term outcomes of SEMS placement and surgery. RESULTS: The 1-, 3-, and 5-year OS rates were 94.1%, 77.4%, and 67.4% (Kaplan-Meier), respectively, with high technical success (99.0%, 206/208) and low perforation (1.9%, 4/208) rates. The 1-, 3-, and 5-year RFS rates were 81.6%, 65.6%, and 57.9% (Kaplan-Meier), respectively, and the overall recurrence rate was 31.0% (62/200). The RFS rate was significantly poorer in patients with perforation (n = 4) than in those without perforation (n = 196) (log-rank P = 0.017); moreover, perforation was identified as an independent factor affecting RFS (hazard ratio 3.31; 95% confidence interval 1.03-10.71, multivariate Cox regression). CONCLUSION: This large, prospective, multicenter study revealed satisfactory long-term outcomes of BTS colonic stenting using a standardized SEMS insertion method, which might be specifically due to the reduced perforation rate. (UMIN000007953).

Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.

PURPOSE: This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2. METHODS: We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. RESULTS: High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group. CONCLUSION: This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.

Endoscopic retrograde cholangiopancreatography using a cap-assisted highly flexible colonoscope in patients with Roux-en-Y anastomosis.

In this retrospective study of 10 patients with Roux-en-Y anastomosis, endoscopic retrograde cholangiopancreatography (ERCP) using a cap-assisted thin highly flexible colonoscope was done for treatment of bile duct stones. In five patients, the papilla of Vater was successfully reached using the colonoscope alone. However, in the other five patients, combination with an overtube was needed to reach the papilla. In all cases, complete removal of bile duct stones was accomplished. Procedure-related adverse events occurred in two cases. In conclusion, use of a cap-assisted thin highly flexible colonoscope for ERCP was successful in patients with a Roux-en-Y anastomosis.

Risk factors of early adverse events associated with endoscopic ultrasound-guided hepaticogastrostomy using self-expandable metal stent.

Background and study aims This retrospective study aimed to investigate risk factors for early adverse events (AEs) associated with endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) using self-expandable metal stents (SEMS). Patients and methods The clinical success rate, technical success rate, and early AEs were assessed at two hospitals from 2010 to 2022. The analysis focused on risk factors associated with cholangitis, peritonitis, and SEMS migration. Results Technical success was achieved in all cases (94/94), and clinical success was 96.8% (91/94). Post-procedural acute cholangitis occurred in 12.8%of cases (12/94). However, no statistically significant risk factors were identified for cholangitis or biliary tract infection. Peritonitis occurred in only 2.1% of cases (2/94). Univariate analysis, using a 1.5 cm cut-off for the distance between the liver and gastrointestinal tract, revealed significant risk factors: braided-type SEMS, bile duct diameter (especially >4 mm), 6 mm diameter SEMS, and tract dilation ( P= 0.001, P= 0.020, P =0.023, and P =0.046, respectively). Adjusting the cut-offs to 2 cm underscored braided-type SEMS and tract dilation as risk factors ( P =0.002 and P =0.046, respectively). With 2.5-cm cut-offs, only braided-type SEMS remained significant ( P =0.018). Mortality within 14 and 30 days following EUS-HGS was 5.3% (5/94) and 16.0% (15/94), respectively. Conclusions EUS-HGS using SEMS demonstrated high technical and clinical success rates. Laser-cut SEMS may be superior in preventing early AEs.

FIB-4 Index and Liver Stiffness Measurement are Potential Predictors of Atherosclerosis in Metabolic Dysfunction-Associated Steatotic Liver Disease.

AIMS: Cardiovascular disease (CVD) is a common cause of death in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Therefore, CVD surveillance is important, but it is not well established. We evaluated the association between liver fibrosis, carotid artery atherosclerosis, and coronary artery stenosis in patients with MASLD. METHODS: Overall, 153 patients with MASLD who underwent carotid artery ultrasound were enrolled. Maximum intima-media thickness including plaques (Max-IMT) was measured by ultrasound. To predict liver fibrosis, liver stiffness was measured by vibration-controlled transient elastography and the fibrosis 4 (FIB-4) index was calculated. Coronary computed tomography angiography was performed to detect coronary artery stenosis based on a Max-IMT of ≥ 1.1 mm. RESULTS: The median Max-IMT was 1.3 mm, and 63 patients (41.2%) had a Max-IMT of ≥ 1.5 mm. FIB-4 index and liver stiffness was significantly correlated with Max-IMT, respectively (ρ=0.356, p＜0.001, ρ=0.25, p=0.002). Liver stiffness was significantly associated with a Max-IMT of ≥1.5 mm, independent of age. Individuals with higher FIB-4 index had moderate or severe coronary artery stenosis more frequently. Individuals with higher LSM level also had moderate or severe coronary artery stenosis more frequently, especially severe stenosis. CONCLUSIONS: Liver fibrosis parameters were associated with carotid artery atherosclerosis and coronary artery stenosis. Evaluation of liver fibrosis may be useful to identify significant atherosclerosis and coronary artery stenosis in patients with MASLD.

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.

BACKGROUND: Endoscopic 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. METHODS: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Long-term outcome of the WallFlex partially covered stent for unresectable malignant biliary obstruction: a multicenter single-arm prospective study.

BACKGROUND/AIMS: Covered metallic stent was developed to prevent tumor ingrowth. However, procedural accidents due to its insertion often occur and migration after long-term insertion causes problems. The WallFlex partially covered stent (WF) with reduced axial force enables stenting along the bile duct. We examined the usefulness of WF placement in an unresectable malignant distal biliary obstruction. METHODOLOGY: We examined procedural accidents, stent obstruction rate, and patency period caused by WF insertion. RESULTS: Ninety-seven patients were analyzed; procedural accidents caused by WF insertion occurred in 8 patients (7.2%) composed of acute cholecystitis in 3 patients (3.2%), acute pancreatitis in 2 patients (2.1%), acute cholangitis in 1 patient (1%), and other in 1 patient (1%). The stent obstruction rate was 19.6% (19 patients), and obstruction cause includes sludge in 9 patients (9.3%), migration in 4 patients (4.1%), food impaction in 3 patients (3.1%), ingrowth in 1 patient (1%), overgrowth in 0 patients (0%), and unknown in 2 patients (2.1%). The mean stent patency period was 634.918 +/- 66.545 (7-946) days. CONCLUSIONS: WF has less procedural accidents when inserted into unresectable malignant biliary obstruction patients with reduced migration rate after a long period and low obstruction rate.

A Japanese Prospective, Multicenter Study of Colonic Stenting for Palliation Using a High Axial Force Self-Expandable Metal Stent for Malignant Large Bowel Obstruction in 200 Patients.

Evidence of the efficacy and safety of colorectal stent placement for palliation remains insufficient. This single-arm, prospective, multicenter study with a WallFlex enteral colonic stent included 200 consecutive patients with malignant large bowl obstruction in the palliation cohort. The technical and clinical success, as well as stent patency and complications as short-term (≤7 days) and long-term (>7 days) outcomes, of high axial force self-expandable metal stent (SEMS) placement was evaluated. The technical and clinical success rates were 98.5% and 94.5%, respectively. Non-recurrent colorectal obstruction at 1 year was 63.9%, and 71.2% of the patients remained free of recurrent colorectal obstruction until death or the last follow-up. Fifty-six patients (28.0%) received chemotherapy, and five patients were administered bevacizumab after stent placement. The overall complication rate was 47%, including four (2.0%) early-onset and ten (5.0%) late-onset perforations, mostly due to stent-edge injury. Only the use of a long SEMS was a risk factor for perforation. In conclusion, endoscopic colorectal stenting using high axial force SEMS is an effective and safe procedure for palliation in patients with malignant colorectal obstruction. However, care should be taken to avoid perforation at the stent edge when using a long SEMS.

WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis-study protocol for a multicentre randomised controlled trial.

BACKGROUND: With the increasing popularity of endoscopic ultrasound (EUS)-guided transmural interventions, walled-off necrosis (WON) of the pancreas is increasingly managed via non-surgical endoscopic interventions. However, there has been an ongoing debate over the appropriate treatment strategy following the initial EUS-guided drainage. Direct endoscopic necrosectomy (DEN) removes intracavity necrotic tissue, potentially facilitating early resolution of the WON, but may associate with a high rate of adverse events. Given the increasing safety of DEN, we hypothesised that immediate DEN following EUS-guided drainage of WON might shorten the time to WON resolution compared to the drainage-oriented step-up approach. METHODS: The WONDER-01 trial is a multicentre, open-label, superiority, randomised controlled trial, which will enrol WON patients aged ≥ 18 years requiring EUS-guided treatment in 23 centres in Japan. This trial plans to enrol 70 patients who will be randomised at a 1:1 ratio to receive either the immediate DEN or drainage-oriented step-up approach (35 patients per arm). In the immediate DEN group, DEN will be initiated during (or within 72 h of) the EUS-guided drainage session. In the step-up approach group, drainage-based step-up treatment with on-demand DEN will be considered after 72-96 h observation. The primary endpoint is time to clinical success, which is defined as a decrease in a WON size to ≤ 3 cm and an improvement of inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, and recurrence of the WON. DISCUSSION: The WONDER-01 trial will investigate the efficacy and safety of immediate DEN compared to the step-up approach for WON patients receiving EUS-guided treatment. The findings will help us to establish new treatment standards for patients with symptomatic WON. TRIAL REGISTRATION: ClinicalTrials.gov NCT05451901, registered on 11 July 2022. UMIN000048310, registered on 7 July 2022. jRCT1032220055, registered on 1 May 2022.

Combination of a 19-gauge needle and 0.018-inch guidewire with a Y-connector during endoscopic ultrasound-guided hepaticogastrostomy.

Video 1.

A case of severe acute hemorrhagic duodenitis after administration of immune checkpoint inhibitor.

Case: A 66-year-old man started carboplatin + etoposide + atezolizumab therapy for advanced small cell lung cancer. Seventeen days after the start of treatment, the patient presented with hematemesis and underwent emergency endoscopy, which revealed multiple erosions and ulcers in the duodenum. Some ulcers showed pulsating bleeding, which was stopped by clipping and cauterization using hemostats. Biopsy of the mucosal peri-ulcer showed lymphocyte, eosinophil, and plasma cell infiltration. The patient was suggested to have acute hemorrhagic duodenitis, which was associated with immune checkpoint inhibitors (ICIs), and conservative treatment with blood transfusion and antacids was continued. However, 11 days after hemostasis, bleeding from a new ulcer was observed. Hemostasis was achieved by coagulation and clipping again, but the general condition of the patient deteriorated owing to the rapid progression of the primary disease, and he died 8 weeks after the start of treatment. Discussion: Although there have been several reports of colitis and other adverse events caused by ICIs, there have been very few reports of duodenitis. Endoscopic findings include diffuse erythema, erosions/ulcerations, and villous atrophy, and pathological findings include eosinophilic infiltration and increased levels of CD8-positive T cells. However, there have been no reports of duodenal mucosal damage caused after administration of atezolizumab nor of severe cases of massive bleeding requiring endoscopic hemostasis and blood transfusion, as in this case.

Extracorporeal rendezvous technique combining endoscopic retrograde pancreatography with endoscopic ultrasound for main pancreatic duct disconnection arising from acute necrotizing pancreatitis: a case report.

Video 1Extracorporeal rendezvous technique combining endoscopic retrograde pancreatography with EUS for main pancreatic duct disconnection arising from acute necrotizing pancreatitis: a case report.

Endoscopic ultrasound-guided pancreaticoduodenostomy with a forward-viewing echoendoscope.

Video 1EUS-guided pancreaticoduodenostomy with a forward-viewing echoendoscope.

[Case of von Hippel-Lindau disease diagnosed by detection of multiple pancreatic endocrine tumors and renal tumor 13 years after bilateral adrenalectomy].

von Hippel-Lindau (VHL) syndrome is an inherited neoplastic syndrome caused by abnormity of the VHL gene found on the short arm of the chromosome 3. We reported a case of VHL disease diagnosed by the detection of multiple pancreatic endocrine tumors and renal tumor 13 years after bilateral adrenalectomy. A 40-year-old man presented with multiple pancreas tumors (maximum size 42 mm in diameter) detected by screening abdominal ultrasonography. A 23 mm renal tumor was detected by contrast computed tomography scan at that time. His past history included left retinal angioma (age 15) and bilateral adrenal pheochromocytoma (age 27). VHL was diagnosed by genetic testing. Endoscopic ultrasound-guided fine-needle aspiration biopsy of the pancreas tumor was performed, and tumor was diagnosed as an endocrine tumor. After diagnosis, distal pancreatectomy (body-tail) was performed. This was a didactic case indicating that we should suspect VHL syndrome based on past history and family history and follow such cases up strictly.

Hemodialysis is a strong risk factor for post-endoscopic sphincterotomy bleeding in patients with choledocholithiasis.

BACKGROUND AND STUDY AIMS: Hemodialysis (HD) is considered one of the risk factors for post-endoscopic sphincterotomy (ES) bleeding. Therefore, we conducted a retrospective study to evaluate HD as a risk factor for post-ES bleeding in patients with choledocholithiasis. PATIENTS AND METHODS: We used the post-ES bleeding rate as the main outcome measure. To evaluate the influence of HD on the risk of post-ES bleeding, logistic regression and propensity score analyses were conducted. In addition, univariate analysis-based comparisons of various clinical parameters (as secondary outcome measures) were performed between the patients in the HD and non-HD groups that experienced post-ES bleeding. RESULTS: A total of 1518 patients were enrolled. In the multivariate analysis, a platelet count of < 50,000, anticoagulant therapy, bleeding during ES, and HD were found to be significantly associated with post-ES bleeding (odds ratio [OR]: 35.30, 95 % confidence interval [CI]: 3.81 - 328.00; OR: 4.39, 95 % CI: 1.53 - 12.60; OR: 4.28, 95 % CI: 2.30 - 7.97; and OR: 13.30, 95 % CI: 5.78 - 30.80, respectively). Propensity score matching created 28 matched pairs. Propensity score analysis showed that the risk difference between the groups was 0.214 (95 % CI: 0.022 - 0.407). In a comparison between the patients in the HD and non-HD groups that suffered post-ES bleeding, it was found that the post-ES bleeding was significantly more severe in the HD group (p = 0.033), and massive blood transfusions and long periods of hospitalization were more frequently required in the HD group (p = 0.008 and p < 0.001, respectively). CONCLUSION: HD is an independent risk factor for post-ES bleeding and makes post-ES bleeding more serious.

Short-course antimicrobial treatment for acute cholangitis with Gram-negative bacillary bacteremia.

OBJECTIVES: The optimal antimicrobial treatment duration for patients with acute cholangitis with bacteremia remains unknown. The updated Tokyo Guidelines 2013 recommend a minimum duration of 2 weeks only when bacteremia with Gram-positive cocci is present. Since May 2013, a shorter antimicrobial treatment duration of under 2 weeks has been implemented at the authors' institution for acute cholangitis with Gram-negative bacillary bacteremia. The aim of the present study was to validate this modified practice. METHODS: A single-center retrospective cohort study was conducted. The antimicrobial treatment duration, 30-day mortality rate, and recurrence rate within 3 months were compared between patients treated before May 2013 and after May 2013. RESULTS: Ninety-one patients with cholangitis with bacteremia were analyzed. The median antimicrobial treatment duration was 14.5days in patients treated before May 2013 and 10.0days after May 2013 (p <0.001). While the 30-day mortality rate did not differ significantly, the recurrence rate was higher in those treated before May 2013 (5.7% vs. 0.0%, p=0.17 and 13.3% vs. 0.0%, p=0.03, respectively). The median treatment duration after May 2013 was 8days for grade I patients, 10days for grade II patients, and 11.5days for grade III patients. CONCLUSIONS: The results of this study suggest that acute cholangitis with Gram-negative bacillary bacteremia can be treated safely with a shorter antimicrobial treatment duration of <14 days.