No registrations found.
ID
Source
Brief title
Health condition
Perihilar cholangiocarcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to assess the feasibility of ucSEMS placement in patients with resectable pCCA defined as:
· At least 70% of patients with technical successful ucSEMS placement, that is:
o Placed in the segment(s) to be drained as determined by the multidisciplinary meeting, with a preferred margin of at least 1 cm proximally and distally across the stenosis
o Bilirubin decrease of at least 20% after 7 days
o No need for additional biliary drainage intervention (ERCP and/or PTCD)
Secondary outcome
The secondary objective of this study is to assess the safety of ucSEMS placement in patients with resectable pCCA by using the following parameters:
· A maximum of 50% of patients with severe post-procedural complications. Complications are defined and subcategorized as:
o Endoscopic (ucSEMS placement)
▪ Moderate or severe post-ERCP pancreatitis: defined as (i) new or worsened abdominal pain; (ii) new or prolonged hospitalization for at least two days; and (iii) serum amylase or lipase > threefold upper limit of normal, measured >24h after the procedure, according to the Atlanta Revised Criteria (17)
▪ Cholangitis, which was defined as both fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. ≥10 *109/L) without clinical or radiological evidence of acute cholecystitis, requiring prolonged antibiotics and re-intervention
▪ Radiologic evidence of cholecystitis, elevation in temperature more than 38.5°C and Leukocytes ≥10*109/L, and requirement of percutaneous drainage or emergency cholecystectomy.
▪ Major Bleeding: defined as a hemoglobin drop of >3g/dl requiring any re-intervention (endoscopic, angiographic, surgical)
▪ Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery
o Stent-related (after placement)
▪ Stent dislocation
▪ Stent occlusion
▪ Bile leakage requiring re-intervention (percutaneous, endoscopic, or surgical)
▪ Intra-abdominal abscess requiring drainage
· Technical success of stent removal, defined as successful removal during surgery by the surgeon on a range from 0 – 10 and duration of removal
· Accuracy of extent of the tumor on CT, MRCP and ERCP in comparison with pathological resection specimens.
Background summary
Biliary drainage in patients with perihilar cholangiocarcinoma is often performed by endoscopic placement of plastic or metal stents. Preoperatively this is mostly limited to plastic stents, but these are known to have limited patency time. The uncovered self-expanding metal stent allows for more rapid biliary decompression and has a reduced occlusion rate when compared to plastic stents. However, there is limited published evidence about the application of ucSEMS in the preoperative setting.
Study objective
Metal stents are safe and a feasible for preoperative biliary draqinage for resectable perihilar cholangiocarcinoma
Study design
Imaging, ERCP (Intervention), surgery (if performed)
Intervention
ucSEMS placement by ERCP
Inclusion criteria
• High suspicion of resectable pCCA on imaging (as determined by the multidisciplinary hepatobiliary team, with or without histopathological confirmation) And
• Preoperative endoscopic drainage is indicated (as determined by the multidisciplinary hepatobiliary team) And
• Written informed consent according to ICH/GCP, and national/local regulations. And
• Age > 18 years
Exclusion criteria
• Patients who underwent previous drainage procedures by endoscopy with plastic stent placement or percutaneously with an (internalized) biliary catheter; And
• Bismuth type I pCCA (as determined by the multidisciplinary hepatobiliary team); And
• Prior diagnosis of Primary Sclerosing Cholangitis (PSC)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9600 |
| Other | METC EMC : MEC-2021-0420 |