Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Not Applicable

• Conditions: Pancreatic Cancer
• Interventions: Procedure: Staging Laparoscopy; Device: Laparoscopic ultrasound

• Registration Number: NCT02479984
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Staging laparoscopy	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.
Staging laparoscopy	Laparoscopic ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Probability of diagnosis of metastasis (frequency)	baseline	Probability of diagnosis of metastasis (frequency)

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of