Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study

Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study - Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055173

Enrollment

Registered

2024-08-13

Start date

2024-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The patient is clinically judged to require biliary drainage due to biliary obstruction caused by pancreatic cancer. 2) The patient is scheduled for biliary drainage by EUS-HGS. 3) Biliary obstruction due to pancreatic cancer is 2 cm below the porta hepatis on the papillary side. 4) There is no history of endoscopic biliary drainage for biliary obstruction due to pancreatic cancer. 5) Invasive pancreatic ductal carcinoma is suspected based on contrast-enhanced CT scan. If contrast-enhanced CT is not available, MRI or EUS is acceptable in addition to simple CT. 6) Pancreatic cancer is evaluated as resectable or borderline resectable by contrast-enhanced CT scan. If contrast-enhanced CT is not available, MRI or EUS is acceptable in addition to simple CT. 7) One of the following (1), (2), or (3) is met. (1) Total bilirubin greater than 1.5 mg/dl, (2) AST greater than 100 U/L, (3) ALT greater than 100 U/L 8) The patient does not have parenchymal jaundice. 9) If the patient is taking antithrombotic medication, it can be withdrawn according to our criteria. 10) No bleeding tendency. 11) ECOG Performance Status less than or equal to 2. 12) Patients must be at least 18 years of age at the time of consent. 13) Written consent for participation in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: 1) The patient is judged by a physician to be inappropriate for enrollment in this study. 2) The patient has a severe case of acute cholangitis according to the severity classification of acute cholangitis. 3) Patients with biliary obstruction due to pancreatic cancer within 2 cm just below the porta hepatis. 4) The patient has a reconstructed intestinal tract after upper gastrointestinal surgery and anatomy does not allow drainage of the biliary tract by EUS-HGS. 5) Patient is anatomically unable to puncture the bile duct in the outer left lobe of the liver, such as after hepatectomy.

Design outcomes

Primary

Measure	Time frame
Clinical success rate	—

Countries

Japan

Contacts

Public ContactShin Yagi

National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology

shyag@ncc.go.jp03-3542-2511

Outcome results