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      • A Prospective, Pilot Study to Evaluate the Safety and Efficacy of the Unity Balloon-Expandable Bioresorbable Biliary Stent System in Subjects with Benign Biliary Strictures

        ( Hairol Othman ),( Zamri Zuhdi ),( Azlanudin Azman ),( Chik Ian ),( Razman Jarmin ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

        Aims: Significant experience with biodegradable biliary stenting has been reported in the literature. The biodegradable stents are typically made from polymeric materials including Polylactide (PLA) or Polyglycolide, which have been approved by the FDA and CE as drug carriers, sutures, and bone fixtures. We have embarked on a pilot study to assess the safety and feasibility of a novel balloon expandable bioresorbable biliary stent. Methods: This is a prospective, pilot, open-label descriptive safety and feasibility study, conducted at UKM Medical Centre, Kuala Lumpur. Patients with benign biliary strictures were recruited. Patients will be follow-up at interval period of weeks 1 and 2, months 1,3,6,9 and 12. The primary objective was to assess safety of the UNITY stent. The secondary objectives were clinical, technical and procedural success. The novel UNITY-B stent comprised of biodegradable magnesium alloy core with biodegradable polymer coating. It degrades through hydrolysis. Results: 6 patients has been recruited from 1 October 2017 until 30 April 2018. Among the indications include; 4 patients with type-2 benign distal common bile duct (CBD) stricture, 1 patient with post-cholecystectomy (Strasberg type E5) stricture, 1 patient with post-operative end-to-end common bile duct anastomotic stricture. At the primary safety endpoint within 30 days of the index procedure, all patients has remained symptom free. Only one patient has reached 6 months follow-up. The secondary objectives were achieved in all 6 patients. Serum bilirubin dropped more than 20% at one week and remained low at 1 month in 5 patients. 1 patient did not show reduction in serum bilirubin but reported improvement in symptoms. 1 patient who has reached 6 month follow-up reported pruritus but has normal serum bilirubin. Conclusions: The UNITY stent has fulfil the safety criteria and has demonstrated good radial force to maintain patency of the stricturoplasty at 1 month. It is easy to be deployed and has the potential to replace the role of covered metal stents. Nonetheless, this is an interim result of a small cohort of patients. A long term data on safety and efficacy of a larger number of patients is anticipated.

      • Single Incision Laparoscopic Cholecystectomy at UKM Medical Centre: An Early Experience

        ( Fatimah Nabila Fauzi ),( Eman Amin ),( Hairol Othman ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

        Aims: Laparoscopic cholecystectomy is the gold standard treatment for gallbladder disease. The technique of using single incision for laparoscopic cholecystectomy is relatively new in Malaysia but it has been widely practiced in other countries. We have embarked on single incision laparoscopic cholecystectomy (SILC) at our institution. The aim of our study is to prove its safety, feasibility as well as patient’s satisfaction. Methods: A total of 48 patients were recruited and underwent SILC at UKMMC between September 2014 to December 2016. All procedures were performed by a single experienced surgeon, under general anaesthesia. A standard 30mm transumbilical incision made for access. We observed the Strasberg critical view of safety in all cases. Technical difficulty was assessed according to Cusheiri scale. Results: 37 patients (77%) were female. The mean age was 50.2 years(range:18 - 80).The mean BMI was 22.9(range:19.0 - 28.1). 7 patients need additional ports (1 port added in 3 patients, 2 ports added in 4 patients). This corelate with higher Cusheiri scale for difficulty. The conversion rates is 14.6%. The mean operating time was 82.3 minutes (range:40 - 170).The operating time varies widely partly due to technical difficulty and patient’s factor. This is also reflected by the long learning curve. The mean score for post operative pain was 3.3 (range:0 - 7) and none reported pain that interrupted daily activities. At 2 weeks follow-up, patients were highly satisfied with resultant scar. The mean satisfaction score was 8.9 (range 7 - 10). 4 patients (8.3%) developed grade 1 SSI at the umbilicus, which resolved with frequent dressing. Conclusions: SILC is technically challenging compared to conventional laparoscopic cholecystectomy. We conclude this technique is safe and feasible with high patients’ satisfaction for cosmesis and less post-operative pain.

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