Exploratory Trial with KOEDA01 in Patients with Acute Cholecystitis.

JRCT ID: jRCT2022230050

Registered date:10/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute cholecystitis
• Date of first enrollment: 04/01/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Placement of an anchor device and drainage tube between the stomach and gallbladder.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 (eGFR<45) or other reasons
11) Patients on antithrombotic drugs (except for aspirin monotherapy)
12) Patients on immunosuppressive drugs and steroids (excluding topical drugs)
13) Patients with serious complications (cerebral infarction (transient ischemic attack is not required if the patient is being treated with antithrombotic drugs (use of single agent aspirin)), severe congestive heart failure (if there is a suspicion of heart failure at screening, echocardiography should be performed and the result is EF <40%), severe stenosis of coronary arteries ( (If there is a finding of suspected coronary artery stenosis at screening, echocardiography should be performed and the result should be 75% or more stenosis), severe arrhythmia, unstable angina, myocardial infarction within 3 months, renal failure (eGFR<45), liver failure, bleeding peptic ulcer, intestinal paralysis or obstruction, poorly controlled diabetes mellitus, etc.). (e.g., 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

Related Information

• Primary Sponsor: Okuzono Toru