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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

Tracking Information
First Submitted Date  ICMJE June 8, 2015
First Posted Date  ICMJE June 24, 2015
Last Update Posted Date September 14, 2017
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
Probability of diagnosis of metastasis (frequency) [ Time Frame: baseline ]
Probability of diagnosis of metastasis (frequency)
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Probability of diagnosis of metastasis (frequency) [ Time Frame: baseline ]
Change History Complete list of historical versions of study NCT02479984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
Official Title  ICMJE A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Procedure: Staging Laparoscopy
  • Device: Laparoscopic ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2015)
193
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sang Jae Park, MD 82-31-920-1640 spark@ncc.re.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02479984
Other Study ID Numbers  ICMJE NCCCTS-11-555
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang-Jae Park, National Cancer Center, Korea
Study Sponsor  ICMJE National Cancer Center, Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Jae Park, MD National Cancer Center, Korea
PRS Account National Cancer Center, Korea
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP