Pancreatic CancerNCT02479984
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
A study testing Staging Laparoscopy and Laparoscopic ultrasound in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Staging Laparoscopy and Laparoscopic ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- > Hb 8.0 g/dl
- > Plt 100 000/mm3
- < Cr 1.2 mg/dl
- > Ccr 60 ml/min/body
Who cannot join
- 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
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- severe respiratory disease requiring continuous oxygen therapy
- liver failure
- systemic administration of corticosteroids
- severe mental disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Sang Jae Park, MD, 82-31-920-1640, spark@ncc.re.kr
About this study
Official title: A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.
Read the 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
- Being tested
- Staging Laparoscopy, Laparoscopic ultrasound
- Keywords
- staging laparoscopy, pancreatic cancer, biliary cancer
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staging LaparoscopyProcedure or surgery
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 ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Staging laparoscopy | Experimental | 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. Receives: Procedure: Staging Laparoscopy; Device: Laparoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of diagnosis of metastasis (frequency)
Probability of diagnosis of metastasis (frequency)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startAug 2011
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang-Jae Park, National Cancer Center, Korea
- Investigators
- Sang Jae Park, MD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479984
- Sponsor's protocol ID
- NCCCTS-11-555
- Status last verified
- Sep 2017
- First submitted
- 8 Jun 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
- ClinicalTrials.gov ID
- NCT02479984
- Acronym / sponsor ID
- NCCCTS-11-555
- Conditions
- Pancreatic Cancer
- Keywords
- staging laparoscopy, pancreatic cancer, biliary cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2011
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staging laparoscopy | Experimental | Procedure: Staging Laparoscopy, Device: Laparoscopic ultrasoundResectable 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. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- cystic neoplasm, neuroendocrine tumors
- pregnant or breast-feeding women
- previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staging LaparoscopyResectable 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 or surgery | Staging laparoscopy |
| Laparoscopic ultrasound | Device | Staging laparoscopy |
Primary outcome
Probability of diagnosis of metastasis (frequency)
Time frame: baseline
Probability of diagnosis of metastasis (frequency)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Jae Park, MD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staging Laparoscopy and Laparoscopic ultrasound in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Jae Park, MD (82-31-920-1640, spark@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of diagnosis of metastasis (frequency) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.