scholarly journals Adjuvant Therapy with Budesonide Post-Kasai Reduces the Need for Liver Transplantation in Biliary Atresia

2021 ◽  
Vol 10 (24) ◽  
pp. 5758
Author(s):  
Joachim F. Kuebler ◽  
Omid Madadi-Sanjani ◽  
Eva D. Pfister ◽  
Ulrich Baumann ◽  
David Fortmann ◽  
...  
Keyword(s):  
Side Effects ◽  
Adjuvant Therapy ◽  
Biliary Atresia ◽  
Experimental Therapy ◽  
Control Group ◽  
Multicenter Observational Study ◽  
Kasai Procedure ◽  
Native Liver ◽  
Survival With Native Liver

Based on the hypothesis that autoimmunological factors coregulate the pathomechanism in biliary atresia (BA), adjuvant therapy with steroids has become routine, although its efficacy has never been proven. In 2010, a study on the advantages of budesonide compared to prednisolone in autoimmune hepatitis gave rise to experimental therapy using budesonide as an adjuvant BA treatment. Ninety-five BA patients prospectively received a budesonide 2 mg/dose rectal foam daily for three months (SG). A case-matched control group (CG: 81) was retrospectively recruited. The outcome measures were survival with native liver (SNL), determined at six months and two years after the Kasai procedure. The follow-up rate was 100%. At six months, SNL was statistically not different but became so after two years (SG: 54%; CG: 32%; p < 0.001). No steroid-related side effects were observed, except for eight patients with finally caught-up growth retardation. This study demonstrates for the first time a significantly longer survival with native liver in patients with BA after adjuvant therapy. However, indication, dosage, and duration of any budesonide application is not given in neonates with BA. Hence, we suggest extending the postoperative use of budesonide in a multicenter observational study with a clearly defined follow-up protocol, particularly in terms of potentially underestimated side effects.

Centralization of Biliary Atresia: Has Germany Learned Its Lessons?

2021 ◽  
Author(s):  
Omid Madadi-Sanjani ◽  
David Fortmann ◽  
Udo Rolle ◽  
Burkhard Rodeck ◽  
Ekkehard Sturm ◽  
...  
Keyword(s):  
Biliary Atresia ◽  
Data Transfer ◽  
Previous Analysis ◽  
Outcome Data ◽  
Free Survival ◽  
Change In Practice ◽  
Native Liver ◽  
Survival With Native Liver ◽  
Pediatric Liver Transplant

Abstract Introduction The majority of pediatric surgeons and hepatologists recommend the centralization of biliary atresia (BA) treatment within experienced liver units. We aimed to investigate whether voluntary self-restriction and acceptance of the need for this change in practice changed the BA referral policy in Germany during the last decade. Materials and Methods In cooperation with pediatric surgeons, gastroenterologists or hepatologists, and pediatric liver transplant units, the 2-year follow-up data of infants with BA born in Germany between 2010 and 2014 were collected using www.bard-online.com or pseudonymized data transfer. Results were compared with our previous analysis of the outcome data of infants with BA born between 2001 and 2005 in Germany. Result Overall, 173 infants with BA were identified, of whom 160 underwent Kasai portoenterostomy (KPE; 92.5%) and 13 (7.5%) underwent primary liver transplantation at 21 German centers. At 2-year follow-up, overall survival was 87.7% (vs. 81.9% in 2001–2005 [p = 0.19]), survival with native liver post-KPE was 29.2% (vs. 22.8% in 2001–2005 [p = 0.24]), and jaundice-free survival with native liver post-KPE was 24.0% (vs. 20.1% in 2001–2005 [p = 0.5]). Compared with the 2001–2005 analysis, all criteria showed improvement but the differences are statistically not significant. Conclusion Our observation shows that KPE management requires improvement in Germany. Centralization of BA patients to German reference liver units is not yet mandatory. However, European and national efforts with regard to the centralization of rare diseases support our common endeavor in this direction.

Prognostic factors indicating survival with native liver after Kasai procedure for biliary atresia

2017 ◽  
Vol 33 (10) ◽  
pp. 1047-1052 ◽  
Author(s):  
Juma Obayashi ◽  
Kohei Kawaguchi ◽  
Shutaro Manabe ◽  
Hideki Nagae ◽  
Munechika Wakisaka ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Biliary Atresia ◽  
Kasai Procedure ◽  
Native Liver ◽  
Survival With Native Liver

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

Kasai Procedure in Patients Older Than 90 Days: Worth a Cut

2021 ◽  
Author(s):  
Marie Uecker ◽  
Joachim F. Kuebler ◽  
Nagoud Schukfeh ◽  
Eva-Doreen Pfister ◽  
Ulrich Baumann ◽  
...  
Keyword(s):  
Treatment Option ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Primary Treatment ◽  
Inclusion Criteria ◽  
Bridge To Transplant ◽  
Kasai Procedure ◽  
Native Liver ◽  
Native Liver Survival

Abstract Introduction Age at Kasai portoenterostomy (KPE) has been identified as a predictive factor for native-liver survival in patients with biliary atresia (BA). Outcomes of pediatric liver transplantation (LT) have improved over recent years. It has been proposed to consider primary LT as a treatment option for late-presenting BA infants instead of attempting KPE. We present our experience with patients older than 90 days undergoing KPE. Materials and Methods A retrospective chart review of patients with BA undergoing KPE at our institution between January 2010 and December 2020 was performed. Patients 90 days and older at the time of surgery were included. Patients' characteristics, perioperative data, and follow-up results were collected. Eleven patients matched the inclusion criteria. Mean age at KPE was 108 days (range: 90–133 days). Results Postoperative jaundice clearance (bilirubin < 2 mg/dL) at 2-year follow-up was achieved in three patients (27%). Eight patients (73%) received a liver transplant at a mean of 626 days (range: 57–2,109 days) after KPE. Four patients (36%) were transplanted within 12 months post-KPE. Two patients died 237 and 139 days after KPE due to disease-related complications. One patient is still alive with his native liver, currently 10 years old. Conclusion Even when performed at an advanced age, KPE can help prolong native-liver survival in BA patients and offers an important bridge to transplant. In our opinion, it continues to represent a viable primary treatment option for late-presenting infants with BA.

scholarly journals Predictors of Successful Kasai Portoenterostomy and Survival with Native Liver at 2 Years in Infants with Biliary Atresia

2019 ◽  
Vol 9 (4) ◽  
pp. 453-459 ◽  
Author(s):  
Ruchika Kumar ◽  
Bikrant B. Lal ◽  
Vikrant Sood ◽  
Rajeev Khanna ◽  
Senthil Kumar ◽  
...  
Keyword(s):  
Biliary Atresia ◽  
Kasai Portoenterostomy ◽  
Native Liver ◽  
Survival With Native Liver

New and safe experimental model of radiation-induced neurovascular histological changes for microsurgical research

2016 ◽  
Vol 51 (2) ◽  
pp. 124-137
Author(s):  
Sergi Barrera-Ochoa ◽  
Irene Gallardo-Calero ◽  
Andrea Sallent ◽  
Alba López-Fernández ◽  
Ramona Vergés ◽  
...  
Keyword(s):  
Side Effects ◽  
Experimental Model ◽  
Experimental Studies ◽  
Neurovascular Bundle ◽  
Control Group ◽  
Sprague Dawley ◽  
Histological Changes ◽  
Group I ◽  
Radiation Induced

The aim is to create a new and safe experimental model of radiation-induced neurovascular histological changes with reduced morbidity and mortality for use with experimental microsurgical techniques. Seventy-two Sprague–Dawley rats (250–300 g) were divided as follows: Group I: control group, 24 rats clinically evaluated during six weeks; Group II: evaluation of acute side-effects (two-week follow-up period), 24 irradiated (20 Gy) rats; and Group III: evaluation of subacute side-effects (six-week follow-up period), 24 irradiated (20 Gy) rats. Variables included clinical assessments, weight, vascular permeability (arterial and venous), mortality and histological studies. No significant differences were observed between groups with respect to the variables studied. Significant differences were observed between groups I vs II–III regarding survival rates and histological changes to arteries, veins and nerves. Rat body weights showed progressive increases in all groups, and the mortality rate of the present model is 10.4% compared with 30–40% in the previous models. In conclusion, the designed model induces selective changes by radiotherapy in the neurovascular bundle without histological changes affecting the surrounding tissues. This model allows therapeutic experimental studies to be conducted, including the viability of microvascular and microneural sutures post radiotherapy in the cervical neurovascular bundle.

Adjuvant therapy with imatinib in gastrointestinal stromal tumor (GIST) patients with intermediate or high risk: Analysis from a single-center contrast study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10556-10556
Author(s):  
J. Li ◽  
F. J. Gong ◽  
J. Li ◽  
W. A. Wu ◽  
L. Shen
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Therapy Group ◽  
Tumor Resection ◽  
Control Group ◽  
Contrast Study ◽  
Complete Tumor Resection ◽  
Free Survival ◽  
Complete Tumor

10556 Background: Imatinib benefits the patients with metastatic GIST but whether it is effective in the adjuvant setting after complete tumor resection of primary GIST is questionable. Methods: Patients who had undergone complete tumor resection with intermediate or high risk of recurrence (define) were enrolled in a single-center non-randomized open contrast study. Patients had adjuvant therapy with imatinib (400mg once a day) for 3 years commencing within 12 weeks of tumor resection, or had follow-up alone. We performed c-kit and PDGFRA mutation analysis for patients with archival tumor samples. The primary objective was recurrence-free survival (RFS) and the second objective was correlation of gene mutation profile with efficacy of adjuvant therapy. Results: One hundred and five patients were enrolled: 56 patients in adjuvant therapy group and 49 patients in control group. Median follow-up was 30 months (range 12–62); Median treatment duration in adjuvant therapy group were 20 months (range 12–36); There was relatively higher 1-year and 2-year RFS in the adjuvant therapy group compared with the control group (100% vs 89.8%,94.4% vs 60.0%) (Log-RankP< 0.001). Hazard risk was 0.13 (95% CI 0.039–0.438, P= 0.001) in Cox proportional hazard regression model. For further sub-group analysis, Log-rank and Cox regression analysis showed that adjuvant therapy could significantly decrease recurrence risk in patients with high risk disease (define)(2-year RFS: 91.5% vs 46,2%, Log-Rank: P<0.001, HR:0.107 (95%CI 0.031–0.370), P<0.001). c-kit and PDGFRA mutation were analyzed in forty-nine patients. There was a better survival benefit from adjuvant therapy for patients with c-kit exon 11 mutation. Conclusions: Adjuvant therapy with imatinib can improve 1-year and 2-year recurrence-free survival for patients with an intermediate or high risk of recurrence after complete tumor resection. No significant financial relationships to disclose.

Survival analysis of maintenance therapy with capecitabine (Cape) in patients with resected pancreatic adenocarcinoma (PAC) after adjuvant therapy: A retrospective cohort study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14658-e14658
Author(s):  
Xuezhong Yang ◽  
Benjamin Weinberg ◽  
Jimmy J. Hwang ◽  
Christina Sing-Ying Wu ◽  
Madeeha Akram ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Maintenance Therapy ◽  
Survival Data ◽  
Prolonged Exposure ◽  
Cancer Center ◽  
Control Group ◽  
Study Group

e14658 Background: The 5-year survival of PAC with surgery alone is below 10%, and with adjuvant chemotherapy increases to about 20%. The original GITSG adjuvant study demonstrating a survival benefit compared to surgery could be attributed to the use of 2-years of weekly IV bolus 5FU, and not only chemoradiation. In theory, the prolonged exposure to therapy could maintain pressure on dormant cancer cells that may remain in G0 arrest, by attacking them as they infrequently enter G1/S phase. To evaluate this hypothesis, we retrospectively evaluated our pts who were treated with or without maintenance Cape. Methods: Pts in the Georgetown/Lombardi Cancer Center EMR since Oct 2007 were sought for PAC that was resected with curative intent, received standard adjuvant chemotherapy with or without chemoradiation. The study group received maintenance cape for at least 2 months, and the control group was monitored until disease recurrence. Only pts with complete follow-up survival data were analyzed. Results: 20 pts met the criteria as study group, and 58 pts as the control group. In the study group, cape was usually given 1000mg orally twice a day, Monday through Friday following adjuvant therapy, for an indefinite period, up to 2 years. Pts received cape for median duration of 12.5 months (2 to 24 months), and the median follow-up duration was 33 months (16 to 78 months). The median overall survival (OS) for the study group was 48 months. The 2 year OS was 94%, and 5 year OS was 40%. The median recurrence free survival (RFS) was 39 months. The 2 year RFS was 67%, and the 5 year RFS was 25%. Common toxicities were mild hand-and-foot syndrome and fatigue. 4 pts discontinued cape due to toxicities: febrile neutropenia, severe fatigue, weight loss and diarrhea. The control group was of comparable staging, and the median OS was 22 months, 5 year OS rate was 16%, median RFS was 13 months, 2 year RFS was 19%. Conclusions: In this single institute retrospective controlled cohort study, Cape maintenance therapy following adjuvant therapy in resected PAC is associated with a significantly (p<0.05) higher OS and PFS compared to the control group. This approach should be studied in a RCT.

Intraoperative Application of Mitomycin C in the Surgical Treatment of Pterygium

1998 ◽  
Vol 8 (3) ◽  
pp. 153-156 ◽  
Author(s):  
A. Demirok ◽  
S. Simsek ◽  
A. Çinal ◽  
T. Yasar
Keyword(s):  
Statistical Analysis ◽  
Surgical Treatment ◽  
Side Effects ◽  
Mitomycin C ◽  
Surgical Excision ◽  
Control Group ◽  
Exact Test ◽  
Pterygium Surgery ◽  
Group 1

Purpose To investigate the effectiveness of intraoperative mitomycin C in pterygium surgery. Methods The effectiveness of intraoperatively administered mitomycin C and the occurrence of postoperative complications were evaluated in 17 patients with two recurrences of pterygium. The authors employed the “bare-sclera technique” and placed a sterile sponge soaked in a 0.02% mitomycin C solution intraoperatively in the episcleral space for 3 minutes. The control group (15 patients) underwent only surgical excision. Patients were followed for 21 to 30 months. Results The pterygium recurred in one (5.9%) of the 17 patients in group 1 and in six (40%) of the 15 controls. Statistical analysis using Fisher's exact test showed a significant (p=0.027) reduction of recurrences of pterygium in the group treated intraoperatively with mitomycin C. No serious complications or side effects arose during the follow-up period. Conclusions Mitomycin C administered intraoperatively can be considered an effective treatment to improve the success rate after surgical excision.

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