1.Efficacy of Hypertonic Saline-Epinephrine Local Injection Around the Anal Side before Endoscopic Papillectomy for Ampullary Tumors
Naoki OKANO ; Yoshinori IGARASHI ; Ken ITO ; Saori MIZUTANI ; Hiroki NAKAGAWA ; Kouji WATANABE ; Yuuto YAMADA ; Kensuke YOSHIMOTO ; Yuusuke KIMURA ; Susumu IWASAKI ; Kensuke TAKUMA ; Seiichi HARA ; Yuui KISHIMOTO
Clinical Endoscopy 2021;54(5):706-712
Background/Aims:
Bleeding is a complication of endoscopic snare papillectomy for ampullary tumors. This study aimed to investigate the clinical efficacy of hypertonic saline-epinephrine (HSE) local injection before endoscopic papillectomy for prevention of bleeding.
Methods:
We retrospectively reviewed the data of 107 consecutive patients with ampullary tumors who underwent endoscopic papillectomy. The rates of en bloc resection, pathological resection margins, and prevention of immediate or delayed bleeding in the simple snaring resection group (Group A) and the HSE injection group (Group B) were compared.
Results:
A total of 44 and 63 patients were enrolled in Groups A and B, respectively. The total complete resection rate was 89.7% (96/107); the clinical complete resection rates in Group A and Group B were 86.3% (38/44) and 92.1% (58/63), respectively (p=0.354). Post-papillectomy bleeding occurred in 22 patients. In Groups A and B, the immediate bleeding rates were 20.5% (9/44) and 4.8% (3/63), respectively (p=0.0255), while the delayed bleeding rates were 7% (3/44) and 11% (7/63), respectively (p=0.52). The rates of positive horizontal and vertical pathological margin in both groups were 27% and 16%, respectively.
Conclusions
HSE local injection was effective in preventing immediate bleeding and was useful for safely performing endoscopic papillectomy for ampullary tumors.
2.Efficacy of Hypertonic Saline-Epinephrine Local Injection Around the Anal Side before Endoscopic Papillectomy for Ampullary Tumors
Naoki OKANO ; Yoshinori IGARASHI ; Ken ITO ; Saori MIZUTANI ; Hiroki NAKAGAWA ; Kouji WATANABE ; Yuuto YAMADA ; Kensuke YOSHIMOTO ; Yuusuke KIMURA ; Susumu IWASAKI ; Kensuke TAKUMA ; Seiichi HARA ; Yuui KISHIMOTO
Clinical Endoscopy 2021;54(5):706-712
Background/Aims:
Bleeding is a complication of endoscopic snare papillectomy for ampullary tumors. This study aimed to investigate the clinical efficacy of hypertonic saline-epinephrine (HSE) local injection before endoscopic papillectomy for prevention of bleeding.
Methods:
We retrospectively reviewed the data of 107 consecutive patients with ampullary tumors who underwent endoscopic papillectomy. The rates of en bloc resection, pathological resection margins, and prevention of immediate or delayed bleeding in the simple snaring resection group (Group A) and the HSE injection group (Group B) were compared.
Results:
A total of 44 and 63 patients were enrolled in Groups A and B, respectively. The total complete resection rate was 89.7% (96/107); the clinical complete resection rates in Group A and Group B were 86.3% (38/44) and 92.1% (58/63), respectively (p=0.354). Post-papillectomy bleeding occurred in 22 patients. In Groups A and B, the immediate bleeding rates were 20.5% (9/44) and 4.8% (3/63), respectively (p=0.0255), while the delayed bleeding rates were 7% (3/44) and 11% (7/63), respectively (p=0.52). The rates of positive horizontal and vertical pathological margin in both groups were 27% and 16%, respectively.
Conclusions
HSE local injection was effective in preventing immediate bleeding and was useful for safely performing endoscopic papillectomy for ampullary tumors.
3.Survey on Role,Responsibility and Skill to Clarify the Medical Science Liaison in Pharmaceutical Companies―Result of the Questionnaire Survey in 2017―
Yukio MORITSUGU ; Hirohisa MIZUNO ; Hideyuki SHIBA ; Kouichi KONNO ; Kouji IWASAKI
Japanese Journal of Drug Informatics 2018;20(3):156-172
Objective:The purpose of this survey was to identify the roles,responsibilities and skills of medical science liaisons(MSLs) in Japan. In addition,we compared to the prior survey results in 2011,2013 and 2015.Method:We contacted 47 pharmaceutical companies with a questionnaire survey on MSLs which included 22 items and analyzed the anonymized results using a web response system.Results:The total number of MSLs increased compared to prior surveys(ranged from 0 to 110). Many companies need MSLs with medical professional qualifications and sophisticated medical expertise. The roles and responsibilities MSLs were expected to perform included managing thought leaders(TL)and/or key opinion leaders (KOL)and implementing medical strategies. On the other hand, issues reported included management of MSLs and cooperation with other stakeholders in the company,and a still low level of recognition of MSLs.Conclusion:The roles of MSL are diverse,and while their activities and status are becoming established they are not yet unified across companies. It is recommended that at the earliest opportunity the roles,responsibilities and key performance indicators(KPI)of MSLs are defined,and educational programs established so that they can act as effective liaisons with medical professionals.
4.The Roles, Organizational Structure, Responsibilities, Recruitment, Skills, Performance Indicators and Future Trends of Medical Science Liaison in Japan―Results of a 2019 Questionnaire
Yukio MORITSUGU ; Hirohisa MIZUNO ; Hideyuki SHIBA ; Kouichi KONNO ; Kouji IWASAKI
Japanese Journal of Drug Informatics 2020;22(2):59-82
Objective: The purpose of this survey was to identify the roles, organizational structure, responsibilities, recruitment, skills, performance indicators and future trends of Medical Science Liaisons (MSLs). In addition, we compared the trend of changes with past surveys.Method: We contacted 52 pharmaceutical companies with a questionnaire survey on MSLs which included 28 items and analyzed the anonymized results using a web response system in Japan.Results: Responses were received from 40 companies (76.9%). The range of MSLs in each company was 0 to 80, the average number for companies withone or more MSLs was 23.6 (median was 13.0). Except for one company, the definition of “MSL” was generally the same. Except for one company, MSLs operated independently of the sales promotion activities. One MSL was responsible for an average of 21 Key Opinion Leader/Key Thought Leaders (KOL/KTL). The key performance indicators (KPI) for MSL activities mainly focused on quantitative indicators such as the number of information collections from KOL/KTL. On the other hand, qualitative indicators were also incorporated suchas feedback from KOL/KTL. “Knowledge of clinical medicine” and “Communication skills” were necessary skills for all companies. 41.9% of companies had an in-house certification program. Some companies will retain and/or decrease the number of MSLs in the future. MSLs were required to have advanced medical expertise as well as medical professional qualifications, and it was confirmed that there are various options for career plans such as MA, R&D, and promotional departments. No matter what the MSL’s therapeutic area (TA), many companies had high expectations for their activities.Conclusion: The current status of expected mission and responsiblities, KPI, size and career plans for MSL were revealed. Companies want MSL’s to play a central role in the inplementation of medical strategies and contribute to internal and external stakeholders.