UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058032 |
|---|---|
| Receipt number | R000066261 |
| Scientific Title | Comparison of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for pancreatic neoplasm: a randomized controlled trial |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/06/09 00:45:27 |
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Basic information
Public title
Comparison of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for pancreatic neoplasm: a randomized controlled trial
Acronym
COROLA-SPDP trial
Scientific Title
Comparison of robotic versus laparoscopic approach in spleen preserving distal pancreatectomy for pancreatic neoplasm: a randomized controlled trial
Scientific Title:Acronym
COROLA-SPDP trial
Region
| Japan |
Condition
Condition
Benign or low-grade malignant tumors in the body and tail of the pancreas
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the spleen-preserving distal pancreatectomy (including pancreatic tail resection) for benign / low-grade malignant tumors of the pancreas, we evaluate the usefulness of a procedure of robotic approach compared to a conventional procedure of laparoscopic approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spleen preservation rate by preserving the splenic artery and vein
Key secondary outcomes
Surgical data: surgery time, laparotomy conversion rate, blood loss, blood transfusion, spleen preservation rate in the resected pancreatic parenchymal length >5cm and <5cm groups, number of sutures for hemostasis in the splenic artery and vein
Postoperative complications: splenic artery and vein patency rate 3 months after surgery, incidence rate of partial splenic infarction of 50% or more, incidence of each Grade of pancreatic fistula, incidence of delayed gastric excretion (DGE) Grade B/C, incidence of intraperitoneal hemorrhage (PPH) Grade B/C, incidence of all postoperative complications, surgical death proportion
Pathological diagnosis: histopathological diagnosis, tumor size
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standard treatment group (group A): Laparoscopic approach
In the laparoscopic approach group, spleen-preserving distal pancreatectomy is performed laparoscopically, preserving the splenic artery and vein.
Interventions/Control_2
Experimental treatment group (group B): Robotic approach
In the robotic approach group, spleen-preserving distal pancreatectomy is performed laparoscopically, preserving the splenic artery and vein, using a robot-assisted system.
Any model of robot is acceptable.
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) Spleen-preserving distal pancreatectomy is planned for pancreatic tumors (however, preoperative biopsy is not required and clinical diagnosis is acceptable). Pancreatic metastasis from renal cancer without preoperative treatment is acceptable.
2) ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
3) Age is over 18 years old.
4) He/she has sufficient judgment to understand the content of the research and has obtained written consent from the person himself/herself.
Key exclusion criteria
1) Patients diagnosed with pancreatic adenocarcinoma or invasive intraductal papillary mucinous carcinoma (IPMC) by imaging diagnosis
2) Patients with severe ischemic heart disease
3) Patients with cirrhosis or active hepatitis requiring treatment
4) Patients with dyspnea requiring oxygen administration
5) Patients undergoing dialysis due to chronic renal failure
6) Long-term oral steroids that may affect adverse events
7) Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
8) Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
9) Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
10) Cases where combined resection of organs other than the gallbladder, bladder, and uterine appendages is suspected to be necessary
11) Other subjects deemed inappropriate by the principal investigator or investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Ei |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
2591193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
Homepage URL
ei.shigenori.h@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
Tel
0463931121
tokai-rec@tokai.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
東京医科大学病院 （東京都）
国際医療福祉大学成田病院 （千葉県）
東京慈恵会医科大学附属病院（東京都）
獨協医科大学埼玉医療センター（埼玉県）
順天堂大学医学部附属順天堂医院（東京都）
日本医科大学付属病院（東京都）
富山大学附属病院 （富山県）
名古屋大学医学部附属病院 （愛知県）
滋賀医科大学医学部附属病院 （滋賀県）
京都府立医科大学附属病院 （京都府）
兵庫医科大学病院 （兵庫県）
大阪公立大学医学部附属病院 （大阪府）
大阪医科薬科大学病院 （大阪府）
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066261
