Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

NCT ID: NCT02479984

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Staging Laparoscopy

Intervention Type: PROCEDURE

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.

Laparoscopic ultrasound

Intervention Type: DEVICE

Interventions

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.

Intervention Type: PROCEDURE

Laparoscopic ultrasound

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sang-Jae Park

Center for Liver Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Jae Park, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Jae Park, MD

Role: CONTACT

spark@ncc.re.kr

82-31-920-1640

Facility Contacts

Sang Jae Park, MD

Role: primary

spark@ncc.re.kr

82-31-920-1640

Other Identifiers

NCCCTS-11-555

Identifier Type: -

Identifier Source: org_study_id