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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02479984

Enrollment

193

Registered

2015-06-24

Start date

2011-08-31

Completion date

2019-12-31

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

staging laparoscopy, pancreatic cancer, biliary 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.

Interventions

PROCEDUREStaging 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.

DEVICELaparoscopic ultrasound

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Probability of diagnosis of metastasis (frequency)	baseline	Probability of diagnosis of metastasis (frequency)

Countries

South Korea

Contacts

Primary ContactSang Jae Park, MD

spark@ncc.re.kr82-31-920-1640

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026