Prospective feasibility study of a novel rigidizing stabilizing overtube in the resection of complex gastrointestinal polyps.

BACKGROUND: A novel rigidizing overtube (ROT) was developed to facilitate endoscopic removal of complex gastrointestinal polyps. We aimed to prospectively evaluate the efficacy and safety of the device in the management of large gastrointestinal polyps. METHODS: A prospective, single-center study, conducted between May 2021 and April 2023, enrolled patients undergoing endoscopic resection of colon/duodenal polyps ≥25 mm. Primary outcomes were safety, technical success, and clinical success defined as the ability of ROT to facilitate endoscopic polyp removal without changing the initial resection method. RESULTS: 97 patients (98 polyps), with a mean polyp size of 33.2 mm (median 31.1), were evaluated. Technical and clinical success rates were 100% and 84%, respectively. Ileocecal valve location was the only predictor of clinical failure (P = 0.02). The mean time to reach the lesion was 7.2 minutes (95%CI 5-8), with overall resection and procedure times of 53.6 minutes (95%CI 48-61) and 88.9 minutes (95%CI 79-95), respectively. No device-related adverse events occurred. Lower technical (67%) and clinical (67%) success rates were seen for duodenal polyps (n = 6). CONCLUSION: The novel ROT was safe, with high technical and clinical success during resection of complex colon polyps. Future studies will determine timing of implementation during routine endoscopic resection.

Predictors of residual neoplasia after noncurative (R1) endoscopic submucosal dissection of lesions in the gastrointestinal tract.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a minimally invasive resection technique that enables the en bloc resection of gastrointestinal lesions. Despite en bloc resection, pathological evaluation of lesions can reveal positive vertical or horizontal margins, which is referred to as R1 resection. Not all R1 lesions referred for surgical resection or endoscopic surveillance show evidence of residual tumor. We aimed to identify the predictors of residual neoplasia in patients with an R1 resection following ESD. PATIENTS AND METHODS: All lesions resected via ESD between June 2016 and September 2021 at a tertiary referral center were retrospectively identified. Lesions with an R1 resection and adequate follow-up were eligible for inclusion. Patient, lesion, and procedural characteristics were analyzed to identify predictors of residual neoplasia. RESULTS: Of 614 lesions, 163 (28%) had R1 resection. Of these, 56 lesions in 51 patients had complete follow-up and were included. Thirteen patients (25.5%) underwent surgical resection and the remainder underwent endoscopic surveillance. Seven (12.5%) patients had residual disease. All patients with residual disease had esophageal carcinoma. Positive deep and lateral margins, severe submucosal fibrosis, and moderate/poorly differentiated tumors were identified as significant predictors of residual neoplasia. CONCLUSION: Most R1 lesions (87.5%) resected by ESD did not have residual disease on follow-up. Those without identified risk factors for residual disease, such as esophageal carcinoma, severe submucosal fibrosis, or both histological margin positivity, may benefit from a strategy of close endoscopic surveillance rather than referral for surgical resection.

Outcomes of endoscopic submucosal dissection in cirrhotic patients: First American cohort.

BACKGROUND: Among patients with cirrhosis and pre-malignant or early malignant mucosal lesions, surgical intervention carries a much higher bleeding risk. When such lesions are discovered, endoscopic submucosal dissection (ESD) may offer curative therapy with lower risks than surgery and improved outcomes compared to traditional endoscopic resection. AIM: To evaluate the outcomes of ESD in patients with cirrhosis. METHODS: Patients with cirrhosis undergoing ESD between July 2015 and August 2022 were retrospectively matched in 1:2 fashion to controls based on lesion location, size, and anticoagulation use. Procedural outcomes were compared between groups. RESULTS: A total of 64 Lesions from 59 patients were included (16 cirrhosis, 43 control). There were no differences in patient or lesion characteristics between groups. En bloc and curative resection was achieved in 84.21%, 78.94% of the cirrhosis group and 88.89%, 68.89% of controls, respectively, with no significant differences. Cirrhotic patients had significantly higher rates of intra-procedural coagulation grasper use for control of bleeding (47.37% vs 20%; P = 0.02). There were otherwise no significant differences in adverse event rates. In the 29 patients with follow up, we found higher rates of recurrence in the cirrhosis group compared to controls (40% vs 5.26%; P = 0.019), however this effect did not persist on multivariable analysis controlling for known confounders. CONCLUSION: ESD may be safe and effective in patients with cirrhosis. Most procedure related outcomes were not significantly different between groups. Intra-procedural bleeding requiring use of the coagulation grasper use was expectedly higher in the cirrhosis group given the known effects of liver disease on hemostasis.

Delays in definitive endoscopic resection of previously manipulated colorectal polyps as a risk factor for inferior resection outcomes.

BACKGROUND AND AIMS: Manipulation of colorectal polyps by biopsy, incomplete resection, or tattoo placement under the lesion has been shown to cause submucosal fibrosis and associated inferior outcomes. The effect of delays between index manipulation and definitive resection on the incidence of fibrosis is unknown. METHODS: Patients undergoing EMR of previously manipulated colorectal polyps ≥10 mm from 2016 to 2021 at a tertiary referral center were included. Time from index manipulation to definitive resection and the presence of fibrosis were noted. The effects of fibrosis on EMR outcomes were assessed. RESULTS: Among 221 previously manipulated lesions (180 biopsy, 23 incomplete/failed resection, 1 tattoo under lesion, 17 multiple types of manipulation), 51 (23%) demonstrated fibrosis. Fibrotic lesions were found to have been resected significantly later than nonfibrotic lesions (76 vs 61 days; P = .014). In a multivariate analysis controlling for other predictors of fibrosis, each 2-week delay was associated with a 14% increase in the odds of fibrosis. Fibrotic lesions had inferior outcomes with a lower en-bloc resection rate (8% vs 24%; P = .014) and longer procedure time (71 vs 52 minutes; P < .001). Adverse event and recurrence rates were similar between groups. CONCLUSIONS: Delays in definitive resection of previously manipulated polyps are associated with an increased incidence of fibrosis with time and associated inferior outcomes. Manipulation should be discouraged, and if it occurs, prompt referral and scheduling for definitive resection should be prioritized.

Endoscopic Ultrasound Predicts Risk of Occult Intra-Abdominal Metastases in Localized Gastric Cancer: A Validation Study.

Background: In gastric cancer (GC) patients without imaging evidence of distant metastasis, diagnostic staging laparoscopy (DSL) is recommended to detect radiographically occult peritoneal metastasis (M1). DSL carries a risk for morbidity and its cost-effectiveness is unclear. Use of endoscopic ultrasound (EUS) to improve patient selection for DSL has been proposed but not validated. We aimed to validate an EUS-based risk classification system predicting risk for M1 disease. Methods: We retrospectively identified all GC patients without positron emission tomography (PET)/computed tomography (CT) evidence of distant metastasis who underwent staging EUS followed by DSL between 2010 and 2020. T1-2, N0 disease was EUS "low-risk"; T3-4 and/or N+ disease was "high-risk". Results: A total of 68 patients met inclusion criteria. DSL identified radiographically occult M1 disease in 17 patients (25%). Most patients had EUS T3 tumors (n = 59, 87%) and 48 (71%) patients were node-positive (N+). Five (7%) patients were classified EUS "low-risk" and 63 (93%) were classified "high-risk". Of 63 "high-risk" patients, 17 (27%) had M1 disease. The ability of "low-risk" EUS to predict M0 disease at laparoscopy was 100% and DSL would have been avoided in five patients (7%). This stratification algorithm showed a sensitivity of 100% (95% confidence interval (CI): 80.5-100%) and a specificity of 9.8% (95% CI: 3.3-21.4%). Conclusions: Use of an EUS-based risk classification system in GC patients without imaging evidence of metastasis helps identify a subset of patients at low-risk for laparoscopic M1 disease who may avoid DSL and proceed directly to neoadjuvant chemotherapy or resection with curative intent. Larger, prospective studies are needed to validate these findings.

Upadacitinib Is Safe and Effective for Crohn's Disease: Real-World Data from a Tertiary Center.

Upadacitinib is a selective JAK-1 inhibitor approved for the treatment of rheumatoid arthritis and more recently, ulcerative colitis. Phase II trials demonstrated that upadacitinib induces endoscopic remission in patients with moderate-to-severe Crohn's disease. However, real-world data are lacking. We present a short report on our experience with off-label upadacitinib in patients with CD at a tertiary center. In this cohort of medically refractory patients with CD, treatment with upadacitinib resulted in subjective and objective responses in 25 and 42% of patients, respectively. Even at doses that are considered lower than currently being studied for CD, upadacitinib was associated with a favorable benefit-to-risk profile.

Vedolizumab for perianal fistulizing Crohn's disease: systematic review and meta-analysis.

BACKGROUND/AIMS: Perianal fistulas are a debilitating manifestation of Crohn's disease (CD). Despite the advent of anti-tumor necrosis factor (anti-TNF) therapy, the medical management of fistulizing CD continues to be challenged by unmet needs. We conducted a systematic review and meta-analysis of the effectiveness of vedolizumab for the management of perianal fistulizing CD. METHODS: A search of PubMed, EMBASE and the Cochrane Library was performed from inception to June 2020 for studies reporting rates of perianal fistula healing in CD patients treated with vedolizumab. The primary outcome of interest was complete healing of perianal fistulas and the secondary outcome was partial healing. The pooled fistula healing rates with 95% confidence intervals (CI) were calculated utilizing a random effects model. RESULTS: A total of 74 studies were initially identified, 4 of which met the inclusion criteria. A total of 198 patients with active perianal fistulas were included, 87% of whom had failed previous anti-TNF therapy. The pooled complete healing rate was 27.6% (95% CI, 18.9%-37.3%) with moderate heterogeneity (I2=49.4%) and the pooled partial healing rate was 34.9% (95% CI, 23.2%-47.7%) with high heterogeneity (I2=67.1%). CONCLUSIONS: In a meta-analysis of 4 studies that included 198 patients with perianal fistulizing CD, the majority of whom had failed previous anti-TNF therapy, vedolizumab treatment led to healing of perianal fistulas in nearly one-third of the patients. The lack of high-quality data and significant study heterogeneity underscores the need for future prospective studies of fistula healing in patients receiving anti-integrin therapy.

Endoscopic ultrasound acquired portal venous circulating tumor cells predict progression free survival and overall survival in patients with pancreaticobiliary cancers.

BACKGROUND AND AIMS: Despite recent advances, patients with pancreaticobiliary cancers have a poor prognosis. We previously demonstrated the efficacy of endoscopic ultrasound (EUS) guided acquisition of portal vein (PV) blood for enumeration of circulating tumor cells (CTCs). The aim of this study was to assess PV-CTCs as potential biomarkers for the assessment of progression-free (PFS) and overall survival (OS) in patients with pancreaticobiliary cancers. METHODS: 17 patients with biopsy-proven pancreaticobiliary malignancy were enrolled. CTCs were enumerated from both peripheral and PV blood. All patients were followed until death. PFS and OS were evaluated with the log-rank test and summarized with the use of Kaplan-Meier methods. Unadjusted and adjusted Cox-proportional hazards models were fitted to study the relationship between PV-CTCs and PFS and OS. RESULTS: After 3.5 years of follow-up, all patients had expired. PV-CTCs were detected in all patients (median PV-CTCs 62.0/7.5 mL (interquartile range [IQR] 17-132). The mean PFS in patients with PV-CTCs <185/7.5 mL was significantly longer than patients with PV-CTCs ≥185/7.5 mL (43.3 weeks vs. 12.8 weeks, log-rank p = 0.002). The mean OS in patients with PV-CTCs <185/7.5 mL was significantly longer than patients with PV-CTCs ≥185/7.5 mL (75.8 weeks vs. 29.5 weeks, log-rank p = 0.021). In an adjusted Cox-proportional hazards model, PV-CTCs were significant predictors of both PFS and OS (HR 1.004, p = 0.037; HR 1.004, p = 0.044 respectively). CONCLUSION: In this pilot and feasibility study, EUS-acquired PV-CTCs predicted PFS and OS. Our findings suggest that PV-CTCs can help provide important prognostic data for both providers and patients.

Investigation of Complications Following Port Insertion in a Cancer Patient Population: A Retrospective Analysis.

Central venous access devices, specifically implantable ports, play an essential role in the care of oncology patients; however, complications are prevalent. This retrospective single-institutional review was performed to identify rates of complications from port placement and potential factors associated with these events. A retrospective analysis of 539 cancer patients who underwent port insertion between March 2016 and March 2017 at our institution was conducted. Data examining 18 potentially predictive factors were collected, and multivariate analysis was conducted using logistic regression and odds ratios (ORs) with standard errors to determine predictive factors. Out of 539 patients, 100 patients (19%) experienced 1 complication, and 12 patients (2%) experienced 2 or more complications. An overall lower rate of complications was seen in patients on therapeutic anticoagulation (OR: 0.17, P < .001) or on antiplatelet agents (OR: 0.47, P = .02). No patients on therapeutic anticoagulation developed venous thromboembolism (VTE; 0%). Right-sided port insertion was associated with decreased rates of infection (OR: 0.44, P = .04). Insertion as inpatient was associated with an increased risk for mechanical failure (OR: 4.60, P < .01). This analysis identified multiple predictive factors that can potentially put patients at a higher risk of experiencing complications following port insertion. Our data show lower rates of VTE for patients on anticoagulation or antiplatelet therapy. Further analysis is also necessary to determine why port insertion as an inpatient places patients at a higher risk of complications. This study highlights the risks associated with port placement and prompts the clinician to have an informed discussion with the patient weighing the risks and benefits.

Effect of prophylactic clip placement following endoscopic mucosal resection of large colorectal lesions on delayed polypectomy bleeding: A meta-analysis.

BACKGROUND: The role of prophylactic clipping for the prevention of delayed polypectomy bleeding (DPB) remains unclear and conclusions from prior meta-analyses are limited due to the inclusion of variety of resection techniques and polyp sizes. AIM: To conduct a meta-analysis on the effect of clipping on DPB following endoscopic mucosal resection (EMR) of colorectal lesions ≥ 20 mm. METHODS: We performed a search of PubMed and the Cochrane library for studies comparing the effect of clipping vs no clipping on DPB following endoscopic resection. The Cochran Q test and I 2 were used to test for heterogeneity. Pooling was conducted using a random-effects model. RESULTS: Thirteen studies with a total of 7794 polyps were identified, of which data was available on 1701 cases of EMR of lesions ≥ 20 mm. Prophylactic clipping was associated with a lower rate of DPB (1.4%) when compared to no clipping (5.2%) (pooled OR: 0.24, 95%CI: 0.12-0.50, P < 0.001) following EMR of lesions ≥ 20 mm. There was no significant heterogeneity among the studies (I 2 = 0%, P = 0.67). CONLUSION: Prophylactic clipping may reduce DPB following EMR of large colorectal lesions. Future trials are needed to further identify risk factors and stratify high risk cases in order to implement a cost-effective preventive strategy.

Pre-operative total parenteral nutrition improves post-operative outcomes in a subset of Crohn's disease patients undergoing major abdominal surgery.

BACKGROUND: Despite major advances in the medical management of Crohn's disease (CD), a significant proportion of patients will require surgery within 5 years of diagnosis. Malnutrition is an independent risk factor for adverse post-operative outcomes following gastrointestinal surgery. Data on the value of pre-operative total parenteral nutrition (TPN) in CD patients are mixed and there is a paucity of data in the biologic era. We aimed to define the role of pre-operative TPN in this population. METHODS: This was a retrospective cohort study conducted at a tertiary referral center. CD patients who underwent major abdominal surgery were identified. Patients receiving pre-operative TPN were compared to controls. We compared the incidence of 30-day infectious and non-infectious post-operative complications between the two groups. RESULTS: A total of 144 CD patients who underwent major abdominal surgery between March 2007 and March 2017 were included. Fifty-five patients who received pre-operative TPN were compared to 89 controls. Twenty-one (14.6%) patients developed infectious complications (18.2% in TPN group vs 12.3% in non-TPN group, P = 0.34) and 23 (15.9%) developed non-infectious complications (14.5% in TPN group vs 16.9% in non-TPN group, P = 0.71). In a multivariate analysis, controlling for differences in baseline disease severity and malnutrition between groups, patients receiving pre-operative TPN for ≥60 days had significantly lower odds of developing non-infectious complications (odds ratio 0.07, 95% confidence interval: 0.01-0.80, P = 0.03). Weight loss of >10% in the past 6 months was a significant predictor of post-operative complications. CONCLUSIONS: In a subset of malnourished CD patients, TPN is safe and allows comparable operative outcomes to controls. Pre-operative TPN for ≥60 days reduced post-operative non-infectious complications without associated increase in infectious complications.

Cholangioscopy in the digital era.

Cholangioscopy allows direct visualization and subsequent therapeutic maneuvers of the biliary ductal system. With advances in endoscopic and imaging technology, cholangioscopy has become an important modality for the diagnosis of indeterminate biliary strictures and an essential therapeutic tool for difficult to remove biliary stones. Enhanced imaging and operability of the latest generation cholangioscopes have further expanded their clinical applications to include ductal tumor ablation, gallbladder drainage, access to difficult to reach branches of the biliary tree, and biliary foreign body manipulation. In this review, we discuss the technical evolution of cholangioscopy into the digital era and review the clinical evidence supporting its use in the diagnosis and therapy of biliary tract disease.

Effects of Preoperative Use of Biologic Agents on Operative Outcomes in Crohn's Disease Patients.

Although the effects of biologic agents on postoperative outcomes in Crohn's disease patients have been extensively studied, the effects on intraoperative outcomes, including blood loss, operative time, and length of small bowel resection, remain to be determined. This was a retrospective cohort study at a single tertiary referral center. Crohn's disease (CD) patients who underwent major abdominal surgery were identified. Patients receiving preoperative biologic agents were compared with controls. We compare operative outcomes between groups. A total of 144 patients who underwent major abdominal surgery at the University of Florida between March 2007 and March 2017 were included. One hundred and ten patients (76%) who received preoperative biologic therapy were compared with 34 controls. On univariate analysis, preoperative biologic use was associated with a significantly shorter length of small bowel resection (21.2 cm in biologic group vs 34.5 cm, P = 0.01). There were no significant differences in intraoperative blood loss (100 vs 87.5 mL, P = 0.40) or total operative time (142 vs 154 minutes, P = 0.39) between groups. On multivariate analysis controlling for variables reflecting severity of disease and malnutrition, biologic use remained significantly associated with shorter length of bowel resection (incident rate ratio 0.58, P = 0.04). Preoperative biologic use is associated with a significantly shorter length of bowel resection in CD patients undergoing major abdominal surgery. No negative effects were noted on operative blood loss or total operative time. Our findings allow improved preoperative planning for surgeons and informed decision-making for CD patients undergoing major abdominal surgery.

Perioperative Care of Patients with Inflammatory Bowel Disease: Focus on Nutritional Support.

Patients with inflammatory bowel disease (IBD) commonly require surgery despite the availability of an increasingly large repertoire of powerful immunosuppressive medications for the treatment of IBD. Optimizing patients' care preoperatively is crucial to obtaining good surgical outcomes. This review discusses preoperative assessment and management principles including assessing disease location and activity with cross-sectional or endoscopic imaging, addressing modifiable risk factors (i.e., stopping smoking, weaning steroids, and correcting anemia), and properly managing medications. The major focus of our literature review is the evaluation for malnutrition, a common finding that affects up to 70% of patients with IBD and a well-known, independent risk factor for adverse postoperative outcomes. Our review confirms that whenever feasible, oral or enteral nutrition (EN) is the preferred method of nutritional support; parenteral nutrition (PN) should be reserved for nutritionally deficient IBD patients unable to tolerate EN. In selected patients, recent data demonstrated that the use of preoperative PN resulted in improved nutritional status, fewer postoperative complications, and reduced disease severity. Our review highlights the need for well-designed, prospective trials investigating perioperative nutritional support in patients with IBD. Future studies should perform modern nutritional assessment, standardize for diet, and include patients with UC since this subset of patients is underrepresented in existing studies. In addition, relevant outcome of interest specific to Crohn's disease (CD) patients such as length of small bowel resected, number of anastomoses, and need for an ostomy should be included as these patients may require repeated small bowel resections.

Once Versus Twice-Daily Oral Proton Pump Inhibitor Therapy for Prevention of Peptic Ulcer Rebleeding: A Propensity Score-Matched Analysis.

BACKGROUND: After inpatient management of upper gastrointestinal bleeding (GIB) due to peptic ulcer disease (PUD), oral proton pump inhibitor (PPI) therapy is recommended at discharge to decrease rebleeding risk and improve ulcer healing. Our aim is to determine whether once-daily oral PPI dosing at hospital discharge is associated with inferior 30-day rebleeding outcomes as compared to twice-daily dosing. METHODS: We retrospectively identified 233 patients admitted with signs and symptoms of upper GIB found to be due to PUD on upper endoscopy. After inpatient management, patients discharged on once-daily oral PPI were compared to those discharged on twice-daily therapy. We utilized propensity score matching based on Rockall scores to ensure the two groups were closely matched in terms of their baseline rebleeding risk. Primary outcome was the incidence of rebleeding within 30 days. Secondary outcomes were all-cause mortality, blood transfusion requirement, requirement for interventional radiology or surgery. RESULTS: Overall, 49 patients were discharged on once-daily and 184 on twice-daily PPI. Recurrent bleeding occurred in 18 patients (7.7%) within 30 days. There was no statistically significant difference in recurrent bleeding rates between once-daily (n = 7, 14.3%) as compared to twice-daily PPI (n = 11, 6%) (P = 0.053). In a 1:1 propensity score matched analysis, there was no statistically significant difference in 30-day recurrent bleeding rate between groups (14% once-daily vs. 4% twice-daily, P = 0.159). There were no differences in secondary outcomes. CONCLUSIONS: Once-daily oral PPI dosing at hospital discharge was not associated with inferior outcomes compared to twice-daily dosing in patients hospitalized for upper GIB due to PUD.