Acute cholecystitis Acute cholecystitis
Conditions
Interventions
Placement of an anchor device and drainage tube between the stomach and gallbladder.
Sponsors
Okuzono Toru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are at least 18 years of age at the time of consent, who have given their free and voluntary consent in writing to participate in this clinical trial. 2) Patients diagnosed with acute cholecystitis based on the Guidelines for Acute Cholangitis and Cholecystitis 2018 (3rd edition) (Tokyo Guidelines 2018: TG18) 3) Patients who are not indicated for emergency cholecystectomy, are scheduled for a standby cholecystectomy, and are deemed to require preoperative drainage of the gallbladder 4) Patients with an ASA-PS (American Society of Anesthesiologists physical status) of Class I or Class II. 5) Patients with an ECOG-PS (ECOG Performance Status) of 0 or 1
Exclusion criteria
Exclusion criteria: 1) Patients who are judged by the investigator or subinvestigator to be ineligible for oral endoscopic treatment due to jaw, oral cavity, or gastrointestinal tract conditions 2) Patients undergoing gallbladder drainage via percutaneous percutaneous route 3) Patients with a history of upper gastrointestinal tract reconstruction 4) Patients with a history of surgical bile duct gastrointestinal anastomosis 5) Patients with suspected gallbladder necrosis on contrast-enhanced CT scan 6) Patients with suspected intracholecystic hemorrhage on contrast-enhanced CT scan or abdominal ultrasonography 7) Patients whose contrast-enhanced CT scan shows that the stomach and gallbladder are far apart, and the investigator or subinvestigator determines that it is difficult to implant the device 8) Patients whose contrast-enhanced CT scan shows ascites to the extent that the investigator or subinvestigator determines that participation in this study is undesirable 9) Patients for whom the investigator or subinvestigator determines that the contrast-enhanced CT scan will make it difficult to implant the planned number of anchor devices to be used. 10) Patients who cannot undergo contrast-enhanced CT scan due to renal insufficiency (eGFR70 years old), cilostazol monotherapy and DOAC monotherapy is acceptable) 12) Patients on ongoing use of immunosuppressive drugs and steroids. However, topical steroids and continuous use of prednisolone equivalent of 10 mg/day or less are not permitted. 13) Patients with serious complications(cerebral infarction and transient ischemic attack not prevented recurrently by antithrombotic drugs, severe congestive heart failure (echocardiography if findings suggestive of heart failure at screening, with EF <40%), severe stenosis of coronary arteries (if there is a finding of suspected severe stenosis of coronary arteries at screening, echocardiography is performed and the result is stenosis of 75% or more), severe arrhythmia, unstable angina, myocardial infarction within 3 months, renal failure (eGFR<30), liver failure, bleeding peptic ulcer, intestinal paralysis/bowel obstruction, (e.g., poorly controlled diabetes mellitus). 14) Patients suffering from malignant tumors (without confirmed recurrence in the past 5 years) 15) Patients with serious infections other than acute cholecystitis requiring systemic administration of antimicrobial agents and antivirals (excluding viral hepatitis, epidemic diseases that are expected to recover quickly, acute upper respiratory tract infection, etc.) 16) Patients with a history of serious allergy 17) Patients who are pregnant or may be pregnant 18) Patients who have the desire to become pregnant during the clinical trial period and are unwilling to use adequate contraception using effective contraceptive methods (e.g., condoms, intrauterine devices, oral contraceptives) during the course of this clinical trial 19) Patients participating in a clinical study or clinical trial with other interventions 20) Other patients whom the investigator or subinvestigator determines to be undesirable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Assessment: (1) Percentage of patients who can undergo laparoscopic cholecystectomy within 2 months after the drainage procedure using the investigational device (percentage of patients judged to be eligible for cholecystectomy and percentage of patients who underwent actual cholecystectomy) (2) Procedural success rate of drainage procedures using investigational devices (3) Pain evaluation Safety evaluation: (1) Percentage of anchor device deviation between the time of implantation and retrieval of the investigational device (2) Percentage of anchor devices retrieved with endoscopic forceps (3) Percentage of drainage tubes retrieved with endoscopic forceps (4) Details and causes of the effects (invasion) on the stomach wall and other parts of the stomach when the anchor device and drainage tube were retrieved with endoscopic forceps. (5) Details of other retrieval methods and their impact (invasion) when the anchor device and drainage tube were not retrieved with the endoscopic forceps, and the cause of such invasion. (6) Rates of recurrence of acute cholecystitis after placement of anchor device and drainage tube (7) Frequency and rate of occurrence of cholestatic peritonitis and generalized peritonitis after implantation of anchor device and drainage tube (8) Percentage of cases in which implantation of an investigational device was attempted, but the device could not be implanted and the study was terminated, and the reasons for such discontinuation (9) Adverse events (10) Failure of investigational device | — |
Contacts
Public ContactToru Okuzono
Sendai Kousei Hospital
Outcome results
None listed