UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061741 |
|---|---|
| Receipt number | R000070658 |
| Scientific Title | A Single-Center Prospective Interventional Study Evaluating the Detection Rate of Occult Distant Metastasis and Safety of Staging Laparoscopy Prior to Neoadjuvant Chemotherapy in Patients with Pancreatic Cancer Without Radiological Distant Metastasis |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/29 17:42:36 |
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Basic information
Public title
A Study of the Utility and Safety of Staging Laparoscopy Before Preoperative Chemotherapy in Patients with Pancreatic Cancer Without Distant Metastasis on Imaging
Acronym
SL-PC Study
Scientific Title
A Single-Center Prospective Interventional Study Evaluating the Detection Rate of Occult Distant Metastasis and Safety of Staging Laparoscopy Prior to Neoadjuvant Chemotherapy in Patients with Pancreatic Cancer Without Radiological Distant Metastasis
Scientific Title:Acronym
SL-PC Study
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the detection rate of occult distant metastasis and the safety of staging laparoscopy performed prior to neoadjuvant chemotherapy in patients with pancreatic cancer without radiological evidence of distant metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of occult distant metastasis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Staging laparoscopy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age 18 years or more.
2.Patients with histologically confirmed pancreatic cancer or with a clinical diagnosis strongly suggestive of pancreatic cancer.
3.Patients with resectable or borderline resectable pancreatic cancer without evidence of distant metastasis on standard imaging assessments, including contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI), and/or fluorodeoxyglucose positron emission tomography (FDG-PET).
4.Patients who provide written informed consent to participate in the study.
Key exclusion criteria
1.Patients with severe comorbidities considered to pose a high risk for general anesthesia and pneumoperitoneum.
2.Patients with known extensive intra-abdominal adhesions that are expected to preclude adequate laparoscopic visualization.
3.Patients undergoing treatment for distant metastases from another active malignancy.
4.Pregnant or breastfeeding women.
5.Patients whom the principal investigator considers unsuitable for participation in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Nanno |
Organization
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
TEL
078-382-6302
ynanno@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ishida |
Organization
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate Schoo
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
TEL
078-382-6302
Homepage URL
jnishida38@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBE Univ. Hosp. CTRC
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070658
