Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02479984
• Other study ID #: NCCCTS-11-555
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2015
• Last updated: September 12, 2017
• Start date: August 2011
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2017
• Source: National Cancer Center, Korea
• Contact: Sang Jae Park, MD
• Phone: 82-31-920-1640
• Email: spark[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 193
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT)

2. No evidence of distant metastasis

3. aged 15-80 year old

4. performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale

5. adequate organ functions defined as indicated below

1. WBC 3000 ~ 12 000/mm3

2. > Hb 8.0 g/dl

3. > Plt 100 000/mm3

4. < Cr 1.2 mg/dl

5. > Ccr 60 ml/min/body

Exclusion Criteria:

1. cystic neoplasm, neuroendocrine tumors

2. pregnant or breast-feeding women

3. previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition

1. unstable angina or myocardial infarction within 6 months of the trial

2. unstable hypertension

3. congestive heart failure

4. severe respiratory disease requiring continuous oxygen therapy

5. liver failure

6. systemic administration of corticosteroids

7. severe mental disorder

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of diagnosis of metastasis (frequency)	Probability of diagnosis of metastasis (frequency)	baseline