Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01)
Abstract. Introduction:. Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a novel drainage option for patients with an inaccessible papilla. Although EUS-HGS has clinical benefits in patients for whom endoscopic retrograde cholangiopancreatography (ERCP) has failed, the rates of adverse...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2022-06-01
|
| Series: | Medicine |
| Online Access: | http://journals.lww.com/10.1097/MD.0000000000029408 |
| _version_ | 1818212634474840064 |
|---|---|
| author | Masahiro Itonaga, MD, PhD Masayuki Kitano, MD, PhD Hiroyuki Isayama, MD, PhD Mamoru Takenaka, MD, PhD Takeshi Ogura, MD, PhD Yasunobu Yamashita, MD, PhD Toshio Fujisawa, MD, PhD Kosuke Minaga, MD, PhD Atsushi Okuda, MD, PhD Toshio Shimokawa, PhD |
| author_facet | Masahiro Itonaga, MD, PhD Masayuki Kitano, MD, PhD Hiroyuki Isayama, MD, PhD Mamoru Takenaka, MD, PhD Takeshi Ogura, MD, PhD Yasunobu Yamashita, MD, PhD Toshio Fujisawa, MD, PhD Kosuke Minaga, MD, PhD Atsushi Okuda, MD, PhD Toshio Shimokawa, PhD |
| author_sort | Masahiro Itonaga, MD, PhD |
| collection | DOAJ |
| description | Abstract. Introduction:. Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a novel drainage option for patients with an inaccessible papilla. Although EUS-HGS has clinical benefits in patients for whom endoscopic retrograde cholangiopancreatography (ERCP) has failed, the rates of adverse events (AEs) associated with EUS-HGS, such as bile peritonitis and stent migration, are higher than for other procedures. The development of a dedicated system for EUS-HGS is therefore desirable to reduce the rate of AEs. We developed a dedicated system for EUS-HGS (HG01 system) which is composed of a 19-gauge needle, 0.025-inch guidewire, a thin delivery system for tract dilation, and an antimigration metal stent. This study is designed to evaluate the efficacy and safety of EUS-HGS using the HG01 system in malignant biliary obstruction.
Methods/design:. This is a single-arm multicenter prospective study involving 40 patients across six tertiary centers in Japan. Patients with an unresectable malignant biliary obstruction in whom biliary drainage with ERCP failed, is not possible, or is very difficult will be registered in the study. The primary endpoint is the clinical success rate. The secondary endpoints are the technical success rate, procedure-related AE rate, procedure time, procedure success rate using only the HG01 system, stent patency rate, re-intervention success rate, re-intervention method, survival rate, and distance of movement of the stent position.
Discussion:. We expect use of the HG01 system to reduce the rate of AEs during EUS-HGS, especially bile leakage and stent migration. If the efficacy and safety of EUS-HGS using the HG01 system is confirmed in the present study, it is likely to be considered the first-choice device for use during EUS-HGS. |
| first_indexed | 2024-12-12T05:51:31Z |
| format | Article |
| id | doaj.art-29f0fb51445d46e6aba55455d14f62a9 |
| institution | Directory Open Access Journal |
| issn | 0025-7974 1536-5964 |
| language | English |
| last_indexed | 2024-12-12T05:51:31Z |
| publishDate | 2022-06-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Medicine |
| spelling | doaj.art-29f0fb51445d46e6aba55455d14f62a92022-12-22T00:35:39ZengWolters KluwerMedicine0025-79741536-59642022-06-0110122e2940810.1097/MD.0000000000029408202206030-00001Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01)Masahiro Itonaga, MD, PhDMasayuki Kitano, MD, PhDHiroyuki Isayama, MD, PhDMamoru Takenaka, MD, PhDTakeshi Ogura, MD, PhDYasunobu Yamashita, MD, PhDToshio Fujisawa, MD, PhDKosuke Minaga, MD, PhDAtsushi Okuda, MD, PhDToshio Shimokawa, PhDAbstract. Introduction:. Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a novel drainage option for patients with an inaccessible papilla. Although EUS-HGS has clinical benefits in patients for whom endoscopic retrograde cholangiopancreatography (ERCP) has failed, the rates of adverse events (AEs) associated with EUS-HGS, such as bile peritonitis and stent migration, are higher than for other procedures. The development of a dedicated system for EUS-HGS is therefore desirable to reduce the rate of AEs. We developed a dedicated system for EUS-HGS (HG01 system) which is composed of a 19-gauge needle, 0.025-inch guidewire, a thin delivery system for tract dilation, and an antimigration metal stent. This study is designed to evaluate the efficacy and safety of EUS-HGS using the HG01 system in malignant biliary obstruction. Methods/design:. This is a single-arm multicenter prospective study involving 40 patients across six tertiary centers in Japan. Patients with an unresectable malignant biliary obstruction in whom biliary drainage with ERCP failed, is not possible, or is very difficult will be registered in the study. The primary endpoint is the clinical success rate. The secondary endpoints are the technical success rate, procedure-related AE rate, procedure time, procedure success rate using only the HG01 system, stent patency rate, re-intervention success rate, re-intervention method, survival rate, and distance of movement of the stent position. Discussion:. We expect use of the HG01 system to reduce the rate of AEs during EUS-HGS, especially bile leakage and stent migration. If the efficacy and safety of EUS-HGS using the HG01 system is confirmed in the present study, it is likely to be considered the first-choice device for use during EUS-HGS.http://journals.lww.com/10.1097/MD.0000000000029408 |
| spellingShingle | Masahiro Itonaga, MD, PhD Masayuki Kitano, MD, PhD Hiroyuki Isayama, MD, PhD Mamoru Takenaka, MD, PhD Takeshi Ogura, MD, PhD Yasunobu Yamashita, MD, PhD Toshio Fujisawa, MD, PhD Kosuke Minaga, MD, PhD Atsushi Okuda, MD, PhD Toshio Shimokawa, PhD Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) Medicine |
| title | Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) |
| title_full | Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) |
| title_fullStr | Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) |
| title_full_unstemmed | Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) |
| title_short | Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction (HG01) |
| title_sort | investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy hg01 in malignant biliary obstruction hg01 |
| url | http://journals.lww.com/10.1097/MD.0000000000029408 |
| work_keys_str_mv | AT masahiroitonagamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT masayukikitanomdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT hiroyukiisayamamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT mamorutakenakamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT takeshioguramdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT yasunobuyamashitamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT toshiofujisawamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT kosukeminagamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT atsushiokudamdphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 AT toshioshimokawaphd investigatorinitiatedclinicaltrialtovalidateusefulnessofspecificsystemforendoscopicultrasoundguidedhepaticogastrostomyhg01inmalignantbiliaryobstructionhg01 |