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Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Staging Laparoscopy
Laparoscopic ultrasound
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring staging laparoscopy, pancreatic cancer, biliary cancer

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Staging laparoscopy

Arm Description

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.

Outcomes

Primary Outcome Measures

Probability of diagnosis of metastasis (frequency)
Probability of diagnosis of metastasis (frequency)

Secondary Outcome Measures

Full Information

First Posted
June 8, 2015
Last Updated
September 12, 2017
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02479984
Brief Title
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
Official Title
A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
staging laparoscopy, pancreatic cancer, biliary cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
193 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Staging laparoscopy
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Staging Laparoscopy
Intervention Description
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
Device
Intervention Name(s)
Laparoscopic ultrasound
Primary Outcome Measure Information:
Title
Probability of diagnosis of metastasis (frequency)
Description
Probability of diagnosis of metastasis (frequency)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) No evidence of distant metastasis aged 15-80 year old performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale adequate organ functions defined as indicated below WBC 3000 ~ 12 000/mm3 > Hb 8.0 g/dl > Plt 100 000/mm3 < Cr 1.2 mg/dl > Ccr 60 ml/min/body Exclusion Criteria: cystic neoplasm, neuroendocrine tumors pregnant or breast-feeding women previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition unstable angina or myocardial infarction within 6 months of the trial unstable hypertension congestive heart failure severe respiratory disease requiring continuous oxygen therapy liver failure systemic administration of corticosteroids severe mental disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Jae Park, MD
Phone
82-31-920-1640
Email
spark@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Jae Park, MD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Jae Park, MD
Phone
82-31-920-1640
Email
spark@ncc.re.kr

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

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