NCT02479984

Brief Summary

The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
193

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

8.4 years

First QC Date

June 8, 2015

Last Update Submit

September 12, 2017

Conditions

Pancreatic Cancer

Keywords

staging laparoscopypancreatic cancerbiliary cancer

Outcome Measures

Primary Outcomes (1)

  • Probability of diagnosis of metastasis (frequency)

    Probability of diagnosis of metastasis (frequency)

    baseline

Study Arms (1)

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.

Procedure: Staging LaparoscopyDevice: Laparoscopic ultrasound

Interventions

Staging LaparoscopyPROCEDURE

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.

Staging laparoscopy
Laparoscopic ultrasoundDEVICE
Staging laparoscopy

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract Diseases

Study Officials

  • Sang Jae Park, MD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Jae Park, MD

CONTACT

82-31-920-1640spark@ncc.re.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center for Liver Cancer

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 24, 2015

Study Start

August 1, 2011

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

KR(1)