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Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

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ClinicalTrials.gov Identifier: NCT02479984
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sang-Jae Park, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: Staging Laparoscopy Device: Laparoscopic ultrasound Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 193 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
Study Start Date : August 2011
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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



Primary Outcome Measures :
  1. Probability of diagnosis of metastasis (frequency) [ Time Frame: baseline ]
    Probability of diagnosis of metastasis (frequency)



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479984


Contacts
Contact: Sang Jae Park, MD 82-31-920-1640 spark@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Sang Jae Park, MD    82-31-920-1640    spark@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sang Jae Park, MD National Cancer Center, Korea

Responsible Party: Sang-Jae Park, Center for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02479984     History of Changes
Other Study ID Numbers: NCCCTS-11-555
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Sang-Jae Park, National Cancer Center, Korea:
staging laparoscopy
pancreatic cancer
biliary cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases