Institute for Digestive Health and Liver Diseases

Baltimore, MD, United States

Institute for Digestive Health and Liver Diseases

Baltimore, MD, United States
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Zhu A.X.,Harvard University | Rosmorduc O.,Service dHepatologie | Evans T.R.J.,University of Glasgow | Ross P.J.,King's College | And 11 more authors.
Journal of Clinical Oncology | Year: 2015

Purpose: To compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma (HCC) in a multicenter, multinational, randomized, phase III trial. Patients and Methods Patients with advanced HCC and underlying Child-Pugh class A cirrhosis, who were naive to systemic treatment (N = 720), were randomly assigned to sorafenib plus either erlotinib (n = 362) or placebo (n = 358). The primary end point was overall survival (OS). Results: Median OS was similar in the sorafenib plus erlotinib and sorafenib plus placebo groups (9.5 v 8.5 months, respectively; hazard ratio [HR], 0.929; P = .408), as was median time to progression (3.2 v 4.0 months, respectively; HR, 1.135; P = .18). In the sorafenib/erlotinib arm versus the sorafenib/placebo arm, the overall response rate trended higher (6.6% v 3.9%, respectively; P = .102), whereas the disease control rate was significantly lower (43.9% v 52.5%, respectively; P = .021). The median durations of treatment with sorafenib were 86 days in the sorafenib/erlotinib arm and 123 days in the sorafenib/placebo arm. In the sorafenib/erlotinib and sorafenib/placebo arms, the rates of treatment-emergent serious AEs (58.0% v 54.6%, respectively) and drug-related serious AEs (21.0% v 22.8%, respectively) were similar. AEs matched the known safety profiles of both agents, but rates of rash/desquamation, anorexia, and diarrhea were higher in the sorafenib/erlotinib arm, whereas rates of alopecia and hand-foot skin reaction were higher in the sorafenib/placebo arm. Withdrawal rates for AEs during cycles 1 to 3 were higher in the sorafenib/erlotinib arm. Conclusion: Adding erlotinib to sorafenib did not improve survival in patients with advanced HCC. © 2014 by American Society of Clinical Oncology.


Kantsevoy S.V.,Institute for Digestive Health and Liver Diseases | Kantsevoy S.V.,University of Maryland Baltimore County | Bitner M.,Institute for Digestive Health and Liver Diseases | Piskun G.,LumenR LLC
Surgical Endoscopy and Other Interventional Techniques | Year: 2016

Background: Endoscopic removal of gastrointestinal tract lesions is increasingly popular around the world. We evaluated feasibility, safety, effectiveness, and user learning curve of new endoscopic platform for complex intraluminal interventions. Methods: A novel system, consisting of expandable working chamber with two independent instrument guides (LIG), was inserted into colon. Simulated colonic lesions were removed with endoscopic submucosal (ESD) and submuscular (ESmD) dissection. Results: In all nine in vivo models, an intraluminal chamber and its dynamic tissue retractors (via LIG) provided a stable working space with excellent visualization and adequate access to target tissue. Endoscopic platform facilitated successful completion of 11 en bloc ESDs (mean size 43.0 ± 11.3 mm, mean time 46.3 ± 41.2 min) and eight ESmD (mean size 50.0 ± 14.1 mm, mean time 48.0 ± 21.2 min). The learning curve for ESD using this platform demonstrated three phases: rapid improvement in procedural skills took place during the first three procedures (mean ESD time 98.7 ± 40.0 min). A plateau phase then occurred (procedures 4–7) with mean procedure time 42.0 ± 13.4 min (p = 0.04), followed by another sharp improvement in procedural skills (procedures 8–11) requiring only 16.3 ± 11.4 min (p = 0.03) to complete ESD. Especially dramatic (p = 0.002) was the time difference between the first three procedures (mean time 98.7 ± 40.0 min) and subsequent eight procedures (mean time 29.1 ± 17.9 min). Conclusions: A newly developed endoscopic platform provides stable intraluminal working space, dynamic tissue retraction, and instrument triangulation, improving visualization and access to the target tissue for safer and more effective enbloc endoscopic submucosal and submuscular dissection. The learning curve for ESD was markedly facilitated by this new endoscopic platform. © 2015, Springer Science+Business Media New York.


PubMed | Institute for Digestive Health and Liver Diseases and LumenR LLC
Type: Journal Article | Journal: Surgical endoscopy | Year: 2016

Endoscopic removal of gastrointestinal tract lesions is increasingly popular around the world. We evaluated feasibility, safety, effectiveness, and user learning curve of new endoscopic platform for complex intraluminal interventions.A novel system, consisting of expandable working chamber with two independent instrument guides (LIG), was inserted into colon. Simulated colonic lesions were removed with endoscopic submucosal (ESD) and submuscular (ESmD) dissection.In all nine in vivo models, an intraluminal chamber and its dynamic tissue retractors (via LIG) provided a stable working space with excellent visualization and adequate access to target tissue. Endoscopic platform facilitated successful completion of 11 en bloc ESDs (mean size 43.011.3mm, mean time 46.341.2min) and eight ESmD (mean size 50.014.1mm, mean time 48.021.2min). The learning curve for ESD using this platform demonstrated three phases: rapid improvement in procedural skills took place during the first three procedures (mean ESD time 98.740.0min). A plateau phase then occurred (procedures 4-7) with mean procedure time 42.013.4min (p=0.04), followed by another sharp improvement in procedural skills (procedures 8-11) requiring only 16.311.4min (p=0.03) to complete ESD. Especially dramatic (p=0.002) was the time difference between the first three procedures (mean time 98.740.0min) and subsequent eight procedures (mean time 29.117.9min).A newly developed endoscopic platform provides stable intraluminal working space, dynamic tissue retraction, and instrument triangulation, improving visualization and access to the target tissue for safer and more effective en bloc endoscopic submucosal and submuscular dissection. The learning curve for ESD was markedly facilitated by this new endoscopic platform.


Kantsevoy S.V.,Institute for Digestive Health and Liver Diseases | Bitner M.,Institute for Digestive Health and Liver Diseases | Mitrakov A.A.,Medical Center Russian Federation | Thuluvath P.J.,Institute for Digestive Health and Liver Diseases
Gastrointestinal Endoscopy | Year: 2014

Background Endoscopic submucosal dissection (ESD) is less invasive than surgical resection, but the large mucosal defects after ESD may lead to adverse events necessitating hospitalizations. Objective To evaluate the use of an endoscopic suturing device for closure of large mucosal defects after ESD. Design and Setting Retrospective, single-center study. Patients Twelve consecutive patients underwent ESD. Interventions All lesions were removed by using a previously described ESD technique. The large mucosal defects post-ESD were completely closed with the endoscopic suturing device, and all patients were discharged home with subsequent clinical and endoscopic follow-up. Main Outcome Measurements Bleeding and perforation rates after ESD with mucosal defect closure. Results ESD followed by endoscopic suturing of the mucosal defects was performed in 12 patients (mean age, 64.7 ± 11.2 years, 4 lesions in the stomach, 8 lesions in the colon; mean lesion size, 42.5 ± 14.8 mm) over a period of 8 months. All lesions (100%) were removed en bloc. Closure of post-ESD defects with an endoscopic suturing device was technically feasible and fast (mean closure time, 10.0 ± 5.8 minutes per patient). Only 1 stitch (continuous suturing line) was required for complete closure in 8 patients. In the other 4 patients, the mucosal defect was closed with 2 to 4 separate stitches (mean number of sutures per patient, 1.6 ± 1.0). There were no immediate or delayed adverse events in any of the study patients. Limitations Retrospective study. Conclusions Closure of large post-ESD defects with the Overstitch endoscopic suturing device is technically feasible and fast and can significantly decrease treatment cost by eliminating the need for hospitalization.


Maheshwari A.,Institute for Digestive Health and Liver Diseases | Rankin R.,Johns Hopkins University | Segev D.L.,Johns Hopkins University | Thuluvath P.J.,Institute for Digestive Health and Liver Diseases | Thuluvath P.J.,Georgetown University
Clinical Transplantation | Year: 2012

Background: The clinical characteristics and outcomes of patients with glycogen storage disease (GSD) who undergo liver transplantation (LT) have not been well defined. In this study, our objective was to determine the outcome of LT in patients with GSD and compare it with a comparable group of patients without GSD (matched controls). Methods: UNOS data from 1986 to 2007 were used for this study. For each GSD patient (n=95; men 62%) who was transplanted, three patients (n=285, men 60%) without GSD (case controls) matched for age±fiveyr, year of transplantation and donor risk index (DRI)±0.2 were identified from the UNOS database in a random manner. Unadjusted patient survival was determined by Kaplan-Meier survival analysis and significance determined by log-rank test. Results: The mean age of the group was 17.9yr. GSD patients had lower BMI (22 vs. 24, p=0.002), lower serum bilirubin (2.7 vs. 13.5mg/dL, p<0.0001), higher serum albumin (3.7 vs. 3.1g/dL, p<0.0001), and higher wait-list time (239 vs. 74d, p<0.0001) compared to case controls. Recipient age and DRI were similar between the groups. Tumors were more common in GSD group (13.7% vs. 5%). Patient survival was significantly better (p=0.024) in GSD group at one, five, and 10yr (82%, 76%, and 64%) than non-GSD (73%, 65%, and 59%) group. Conclusions: In this matched-control study, patients who underwent LT for GSD had a better long-term survival than a comparable group of patients without GSD. © 2012 John Wiley & Sons A/S.


Kantsevoy S.V.,Institute for Digestive Health and Liver Diseases | Kantsevoy S.V.,University of Maryland Baltimore County | Bitner M.,Institute for Digestive Health and Liver Diseases | Hajiyeva G.,Institute for Digestive Health and Liver Diseases | And 8 more authors.
Gastrointestinal Endoscopy | Year: 2016

Background and Aims Perforation during colonoscopy remains the most worrisome adverse event and usually requires urgent surgical rescue. The aim of this study was to evaluate the feasibility and effectiveness of endoscopic closure of full-thickness colonic perforations. Methods We performed a retrospective analysis of all consecutive patients with endoscopically closed colonic perforations over the past 6 years (2009-2014). Colonic perforations were closed by using endoscopic clips or an endoscopic suturing device. Most patients were admitted for treatment with intravenous antibiotics and kept on bowel rest. If their clinical condition deteriorated, urgent surgery was performed. If patients remained stable, oral feeding was resumed, and patients were discharged with subsequent clinical and endoscopic follow-up. Results Twenty-one patients had iatrogenic colonic perforations closed with an endoscopic suturing device or endoscopic clips during the study period. Primary closure of a colonic perforation was performed with endoscopic clips in 5 patients and sutured with an endoscopic suturing device in 16 patients. All 5 patients after clip closure had worsening of abdominal pain and required laparoscopy (4 patients) or rescue colonoscopy with endoscopic suturing closure (1 patient). Two patients had abdominal pain after endoscopic suturing closure, but diagnostic laparoscopy confirmed complete and adequate endoscopic closure of the perforations. The other 15 patients did not require any rescue surgery or laparoscopy after endoscopic suturing. The main limitation of our study is its retrospective, single-center design and relatively small number of patients. Conclusion Endoscopic suturing closure of colonic perforations is technically feasible, eliminates the need for rescue surgery, and appears more effective than closure with hemostatic endoscopic clips. © 2016


PubMed | Institute for Digestive Health and Liver Diseases, Center for Minimally Invasive Surgery, The Surgical Center, University of Maryland Baltimore County and Harbor Hospital Center
Type: Journal Article | Journal: Gastrointestinal endoscopy | Year: 2016

Perforation during colonoscopy remains the most worrisome adverse event and usually requires urgent surgical rescue. The aim of this study was to evaluate the feasibility and effectiveness of endoscopic closure of full-thickness colonic perforations.We performed a retrospective analysis of all consecutive patients with endoscopically closed colonic perforations over the past 6 years (2009-2014). Colonic perforations were closed by using endoscopic clips or an endoscopic suturing device. Most patients were admitted for treatment with intravenous antibiotics and kept on bowel rest. If their clinical condition deteriorated, urgent surgery was performed. If patients remained stable, oral feeding was resumed, and patients were discharged with subsequent clinical and endoscopic follow-up.Twenty-one patients had iatrogenic colonic perforations closed with an endoscopic suturing device or endoscopic clips during the study period. Primary closure of a colonic perforation was performed with endoscopic clips in 5 patients and sutured with an endoscopic suturing device in 16 patients. All 5 patients after clip closure had worsening of abdominal pain and required laparoscopy (4 patients) or rescue colonoscopy with endoscopic suturing closure (1 patient). Two patients had abdominal pain after endoscopic suturing closure, but diagnostic laparoscopy confirmed complete and adequate endoscopic closure of the perforations. The other 15 patients did not require any rescue surgery or laparoscopy after endoscopic suturing. The main limitation of our study is its retrospective, single-center design and relatively small number of patients.Endoscopic suturing closure of colonic perforations is technically feasible, eliminates the need for rescue surgery, and appears more effective than closure with hemostatic endoscopic clips.


PubMed | Institute for Digestive Health and Liver Diseases and Privolzhskij Area Medical Center Russia
Type: Journal Article | Journal: Gastrointestinal endoscopy | Year: 2014

Endoscopic submucosal dissection (ESD) is less invasive than surgical resection, but the large mucosal defects after ESD may lead to adverse events necessitating hospitalizations.To evaluate the use of an endoscopic suturing device for closure of large mucosal defects after ESD.Retrospective, single-center study.Twelve consecutive patients underwent ESD.All lesions were removed by using a previously described ESD technique. The large mucosal defects post-ESD were completely closed with the endoscopic suturing device, and all patients were discharged home with subsequent clinical and endoscopic follow-up.Bleeding and perforation rates after ESD with mucosal defect closure.ESD followed by endoscopic suturing of the mucosal defects was performed in 12 patients (mean age, 64.7 11.2 years, 4 lesions in the stomach, 8 lesions in the colon; mean lesion size, 42.5 14.8mm) over a period of 8 months. All lesions (100%) were removed en bloc. Closure of post-ESD defects with an endoscopic suturing device was technically feasible and fast (mean closure time, 10.0 5.8 minutes per patient). Only 1 stitch (continuous suturing line) was required for complete closure in 8 patients. In the other 4 patients, the mucosal defect was closed with 2 to 4 separate stitches (mean number of sutures per patient, 1.6 1.0). There were no immediate or delayed adverse events in any of the study patients.Retrospective study.Closure of large post-ESD defects with the Overstitch endoscopic suturing device is technically feasible and fast and can significantly decrease treatment cost by eliminating the need for hospitalization.


Kantsevoy S.V.,Institute for Digestive Health and Liver Diseases | Kantsevoy S.V.,University of Maryland Baltimore County | Bitner M.,Institute for Digestive Health and Liver Diseases
Gastrointestinal Endoscopy | Year: 2013

Background: Internal hemorrhoids often present with bleeding, prolapse, and other symptoms. Currently used nonsurgical treatment modalities have limited effectiveness and usually require several treatment sessions. Objective: To evaluate effectiveness and safety of a novel endoscopic device for nonsurgical treatment of internal hemorrhoids. Design: Retrospective study. Setting: Single center. Patients: This study involved 23 patients with actively bleeding internal hemorrhoids. Intervention: The HET Bipolar System is a modified anoscope, with a treatment window, light source, and tissue temperature monitor. The device is inserted into the rectum under direct observation. The tissue carrying superior hemorrhoidal branches and the apex of the internal hemorrhoid is positioned inside the treatment window, clamped with incorporated tissue forceps, and treated with bipolar energy to ligate hemorrhoidal feeding vessels. Main Outcome Measurements: Rate of hemorrhoidal bleeding after the treatment. Results: The mean age of the patients was 64.3 ± 9.9 years (range 44-79 years). Eleven patients (47.8%) had grade I hemorrhoids and 12 patients (52.2%) had grade II hemorrhoids. In 18 patients (78.3%), treatment with the HET System was performed with the patient under conscious sedation. Five patients (21.7%) were treated without sedation. All patients tolerated treatment without complaints. The average follow-up period was 11.2 ± 4.7 months. No bleeding or prolapse occurred after the procedure in any of the treated patients. Limitations: Retrospective study. Conclusion: The newly developed HET System is easy to use, safe, and highly effective in eliminating bleeding in grade I and II internal hemorrhoids and prolapse in grade II internal hemorrhoids. Copyright © 2013 by the American Society for Gastrointestinal Endoscopy.


Maheshwari A.,Institute for Digestive Health and Liver Diseases | Thuluvath P.J.,Institute for Digestive Health and Liver Diseases | Thuluvath P.J.,Georgetown University
Clinics in Liver Disease | Year: 2011

Liver disease and endocrine disorders, both common in the general population, have a bidirectional and complex relationship. Certain liver diseases are more commonly associated with endocrine disorders, including nonalcoholic fatty liver disease, autoimmune hepatitis, and primary biliary cirrhosis. There may be an association between hepatitis C and type 2 diabetes mellitus as well as thyroid disorders, and sex hormonal preparations may cause specific hepatic lesions. The presence of relative adrenal insufficiency in patients with end-stage liver disease may have therapeutic implications in patients admitted with acute-on-chronic liver failure. The objective of this review is to focus on the effect of endocrine disorders on liver. © 2011 Elsevier Inc.

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