Bile duct cancers Bile Duct Neoplasms
Conditions
Interventions
Preoperative mapping biopsy with EndoSheather or biliary biopsy is assigned.
Sponsors
Tomoaki Matsumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following must be met. *Cases in which malignant biliary stricture is suspected and a mapping biopsy with the intention of surgery is necessary. *Cases in which a transpapillary bile duct approach using a lateral endoscope is feasible. *Patients who are undergoing mapping biopsy for the first time at the facility. *Patients 20 years of age or older who have been fully informed about the study and who have given their free and voluntary written consent with full understanding.
Exclusion criteria
Exclusion criteria: *Patients who have already undergone mapping biopsy at the institution. *Cases in which mapping biopsy has already been performed at the institution. (A finding suspicious of pancreatic cancer is a case in which the primary location of the mass is thought to be the pancreas on various imaging tests.) *Cases of reconstructed intestinal tracts after bile duct jejunal anastomosis, Billroth II method of reconstruction, Roux-en-Y method, and other postoperative reconstructive methods. (excluding the Billroth I method). *Cases in which the principal investigator (or subinvestigator) determines that the subject is inappropriate for the study. (e.g., patients considered to be at high risk for acute pancreatitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biopsy success rate with assigned devices | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Time required for biopsy (2) Total procedure time and bile duct intubation time (3) Success rate of biopsy procedure (4) Correct specimen collection rate (5) Contingencies (6) Procedure-related device costs (7) Negative bile duct margins in surgically resected specimens (8) Accuracy of endoscopic findings in POCS | — |
Contacts
Public ContactMatsumori Tomoaki
Kyoto university hospital
Outcome results
None listed