COSMIC UNISON study

JRCT ID: jRCT1042230170

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: unresectable malignant distal biliary stricture
• Date of first enrollment: 15/03/2024
• Target sample size: 250
• Study type: Interventional
• Intervention(s): Patients will be assigned randomly to either the control group denoted by the insertion of 10 mm diameter fully covered self-expandable metal stents (FCSEMS), designated as Group A, or the study group denoted by the implantation of 6 mm diameter FCSEMS, designated as Group B, and these will be placed at the site of malignant distal bile duct stenosis through endoscopic retrograde cholangiopancreatography (ERCP).

Outcome(s)

• Primary Outcome: time to recurrent biliary obstruction ; TRBO

Secondary Outcome

Safety secondary endpoint
Incidence of non-RBO events (pancreatitis, non-stent obstructive cholangitis, cholecystitis, bleeding, perforation, other (ulceration, etc.))
Secondary endpoints of efficacy
(1) Non-RBO rate (at 3, 6, and 12 months), (2) survival, (3) cause of RBO (stent occlusion: (Tumor ingrowth or mucosal hyperplasia, Tumor overgrowth, biliary mud (with or without concomitant stones), fitted food residues, biliary bleeding, bile duct kink, other), symptomatic stent Deviation: (hepatic side, papillary side))

Key inclusion & exclusion criteria

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

Include criteria

1.Inoperable malignant stenosis of the distal bile duct (stricturing located more than 2 cm distal to the confluence of the right and left hepatic ducts).
2.Patients possessing a verified diagnosis of malignancy as determined by cytological or histological analysis.
3.Patients exhibiting aberrant levels of total bilirubin, AST, ALT, r-GTP, or ALP, necessitating endoscopic drainage. Deviant values are defined as total bilirubin > 1.5 mg/dl, AST > 100 IU/l, ALT > 100 IU/l, r-GTP > 150 IU/l, and ALP > 250 IU/l according to criteria established by the International Federation of Clinical Sciences (IFCC). If the patient has already undergone endoscopic or percutaneous biliary drainage with a plastic stent and is contemplating conversion to biliary drainage with a metal stent, blood samples taken prior to initial biliary drainage (including premedical values) may be employed to make the determination.
4.Patients who have provided written consent of their own volition, having been fully apprised of the particulars of the study and evincing a thorough comprehension of its objectives.
5.Patients 18 years of age or older at the time of consent.

Exclude criteria

1) Patients who have undergone biliary drainage with a metal stent
2) Patients who are classified as R, BR-PV, or BR-A in the pancreatic cancer resectability classification
3) Patients with Eastern Cooperative Oncology Group performance status 4: PS4
4) Patients with postoperative reconstruction of the upper gastrointestinal tract (excluding Billroth I reconstruction)
5) Patients with serious dysfunction of other organs (American Society of Anesthesiologist physical status classification grade III or IV)
6) Patients with a prognosis of less than 3 months
7) Other subjects who are judged by the principal investigator to be inappropriate as subjects
8) Patients who are pregnant or may become pregnant

Related Information

• Primary Sponsor: Yamada Reiko
• Secondary Sponsor: Nakagawa Hayato
• Source(s) of Monetary Support: Mie University hospital clinical reserch scholarship