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The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 30Ëš 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staging Laparoscopy | Procedure | 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 30Ëš 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of diagnosis of metastasis (frequency) | Probability of diagnosis of metastasis (frequency) | baseline |
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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
Exclusion Criteria:
cystic neoplasm, neuroendocrine tumors
pregnant or breast-feeding women
previous upper abdominal surgery except laparoscopic cholecystectomy 4.Serious illness in medical condition
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Jae Park, MD | Contact | 82-31-920-1640 | spark@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang Jae Park, MD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Laparoscopic ultrasound | Device |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |