NCT02479984

Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.

Detailed description

To evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer. All analyses are performed using SAS version 9.1.3 for Windows (SAS institute, Cary, NC). Clinical and pathological variables will be analyzed using the χ2 test (or Fisher's exact test) and the Student's t test, depending on the normality of the distribution. P-values of \< 0.05 are considering statistically significant.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Staging Laparoscopy	Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) and no evidence of distant metastasis. Staging laparoscopy will perform through 2 ports and a 30˚ laparoscope is inserted into the peritoneal cavity. Examining the whole abdominal wall, including the parietal and visceral peritonea, we will observe the liver surface from the dome area to the inferior surface and hepatoduodenal ligament in order to find metastatic nodules. Laparoscopic ultrasound (US) will be used to overcome in inspecting the posterior part of the liver. After complete laparoscopic examination, peritoneal lavage will be performed through the laparoscopic port.
DEVICE	Laparoscopic ultrasound

Timeline

• Start date: 2011-08-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2015-06-24
• Last updated: 2017-09-14

Locations

1 site across 1 country: South Korea