Clinical trial · Interventional
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer
NCT02479984CI-TRIAL-00029538unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic ultrasound | Device | — | UNRESOLVED |
| Staging Laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Staging laparoscopy
- description
- 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.
- interventionNames
- Procedure: Staging Laparoscopy
- Device: Laparoscopic ultrasound
Primary outcomes (1)
- measure
- Probability of diagnosis of metastasis (frequency)
- timeFrame
- baseline
- description
- Probability of diagnosis of metastasis (frequency)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.