Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Staging Laparoscopy
* Device: Laparoscopic ultrasound


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Staging laparoscopy<br>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<br>* 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.<br>Device: Laparoscopic ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of diagnosis of metastasis (frequency) | Probability of diagnosis of metastasis (frequency) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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staging laparoscopy, pancreatic cancer, biliary cancer