UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057794 |
|---|---|
| Receipt number | R000066035 |
| Scientific Title | A Prospective Study to Evaluate the Safety and Efficacy of Celiac Artery-Preserving Distal Pancreatectomy After Neoadjuvant Therapy for Locally Advanced Pancreatic Body Cancer |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/07 20:11:39 |
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Basic information
Public title
A Study on a New Artery-Preserving Surgery after Preoperative Therapy for Advanced Pancreatic Cancer
Acronym
PANDA Study
Scientific Title
A Prospective Study to Evaluate the Safety and Efficacy of Celiac Artery-Preserving Distal Pancreatectomy After Neoadjuvant Therapy for Locally Advanced Pancreatic Body Cancer
Scientific Title:Acronym
PANDA Study(Pancreatic Advanced Body Cancer treated with Neoadjuvant therapy undergoing Distal pancreatectomy with Artery preservation)
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether, in patients with locally advanced pancreatic body and tail cancer showing suspected involvement of the common hepatic artery (CHA), celiac artery (CA), or proximal splenic artery at initial diagnosis, distal pancreatectomy with celiac artery preservation after neoadjuvant chemotherapy or chemoradiotherapy can reduce postoperative complications without compromising the R0 resection rate, compared to conventional DP-CAR.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of major postoperative complications (Clavien-Dindo classification grade III or higher) within 90 days after surgery
Key secondary outcomes
1. Rate of completion of distal pancreatectomy with celiac artery preservation
2. R0 resection rate (rate of curative resection)
3. Overall survival from the start of neoadjuvant therapy
4. Recurrence-free survival from the start of neoadjuvant therapy
5. Overall survival from surgery
6. Recurrence-free survival from surgery
7. Surgical outcomes (operative time, intraoperative blood loss, need for transfusion, length of postoperative hospital stay)
8. Postoperative complication rates (reoperation rate, readmission rate, surgery-related mortality rate)
9. Response rate and disease control rate to preoperative chemotherapy (per RECIST version 1.1)
10. Normalization rate of tumor markers (CA19-9, CEA) before and after neoadjuvant chemotherapy
11. Histological treatment effect (tumor cell destruction rate based on Evans grading system)
12. Rate of initiation of postoperative adjuvant chemotherapy
13. Details of neoadjuvant therapy (duration, number of chemotherapy cycles, presence or absence of radiotherapy)
14. Disease-specific survival from the end of neoadjuvant therapy
15. Disease-specific survival from surgery
16. Patterns of recurrence
17. Postoperative weight loss rate (at 6 months, 1 year, 2 years, and 3 years after surgery)
18. Changes in postoperative performance status (ECOG scale)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with pancreatic body cancer diagnosed as invasive ductal carcinoma (adenocarcinoma or adenosquamous carcinoma) based on histology, cytology, or imaging findings, and who, at initial diagnosis, underwent disease staging with multidetector computed tomography (MDCT), showing tumor abutment of the common hepatic artery (CHA), the celiac artery (CA), or located within 10 mm of the root of the splenic artery.
2. Patients receiving initial treatment (no prior therapy for pancreatic cancer).
3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Patients aged >=20 years at the time of informed consent.
5. Patients with adequate organ function, as confirmed by laboratory values obtained within 30 days prior to enrollment:
- White blood cell count: <=12,000 /mm3
- Neutrophil count: >=1,500 /mm3
- Hemoglobin: >=9.0 g/dL
- Platelet count: >=100,000 /mm3
- Total bilirubin: <2.0 mg/dL (<=3.0 mg/dL if post-drainage for obstructive jaundice)
- Serum creatinine: <=1.5 mg/dL
- AST and ALT: <=2.5 x institutional upper limit of normal
6. Patients who have provided written informed consent prior to enrollment in this study.
Key exclusion criteria
1. Patients with distant metastases, as defined by the NCCN Guidelines (Version 2.2025) for metastatic disease, based on staging by MDCT.
2. Patients with active infections.
3. Patients who did not provide written informed consent.
4. Patients deemed ineligible for participation in this study by the attending physician for any other reason.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University
Division name
second department of surgery
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
073-447-2300
a-take@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Takeuchi |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
0734472300
Homepage URL
a-take@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City, Wakayama
Tel
0734472300
wa-rinri@wakayama-med.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
| 2025 | Year | 05 | Month | 12 | 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
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, single-center observational study conducted by the Second Department of Surgery, Wakayama Medical University.
It aims to evaluate postoperative outcomes and prognosis in patients who undergo distal pancreatectomy with celiac artery preservation following neoadjuvant chemotherapy or chemoradiotherapy, and to compare the findings with previously reported cases treated with DP-CAR.
The study has been approved by the Ethics Review Committee of Wakayama Medical University (Approval No. 4466).
Management information
Registered date
| 2025 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066035
