UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045912 |
|---|---|
| Receipt number | R000052290 |
| Scientific Title | Short-Term Outcomes of Laparoscopic and Open Distal Pancreatectomy Using Propensity-Score Analysis: A Real-World Retrospective Cohort Study |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/05/01 09:21:10 |
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Basic information
Public title
Short-Term Outcomes of Laparoscopic and Open Distal Pancreatectomy Using Propensity-Score Analysis: A Real-World Retrospective Cohort Study
Acronym
Short-Term Outcomes of Laparoscopic and Open Distal Pancreatectomy
Scientific Title
Short-Term Outcomes of Laparoscopic and Open Distal Pancreatectomy Using Propensity-Score Analysis: A Real-World Retrospective Cohort Study
Scientific Title:Acronym
Short-Term Outcomes of Laparoscopic and Open Distal Pancreatectomy
Region
| Japan |
Condition
Condition
Pancreatic malignancy, Pancreatic benign tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compared short-term surgical outcomes between patients treated with LDP or ODP using a nationwide large-sample dataset to understand the comprehensive real-world impacts of LDP and ODP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality
Key secondary outcomes
morbidity, readmission, reoperation, postoperative length of stay, medical cost
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
| 5 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with bile-pancreas malignancy or patients undergoing targeted surgery for malignancy who underwent distal pancreatectomy from April 2008 to May 2020 from the MDV database.
Key exclusion criteria
Patients who have undergone distal pancreatectomy for other than pancreatic disease.
Missing data on smoking history, stage if cancer, height, and weight.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Taniguchi |
Organization
Osaka Medical and Pharmaceutical University
Division name
Translational Research Program
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki
TEL
0726831221
kohei.taniguchi@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of General and Gastroenterological Surgery
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki
TEL
0726831221
Homepage URL
masato.ota@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical 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
Japan Society of Clinical Research
Address
6-13-16, Ginza, Chuuou-ku, Tokyo
Tel
06-6131-5495
masato.ota@ompu.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
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/annalsofsurgery/abstract/2023/10000/short_term_outcomes_of_laparoscopic_and
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/annalsofsurgery/abstract/2023/10000/short_term_outcomes_of_laparoscopic_and
Number of participants that the trial has enrolled
5502
Results
Laparoscopic distal pancreatectomy was associated with lower inhospital mortality during the period of admission (0.0% vs 0.7%, P<0.001) and within 30 days (0.0% vs 0.2%, P=0.001), incidence of reoperation during the period of admission (0.7% vs 1.7%, P=0.018), postpancreatectomy hemorrhage (0.4% vs 2.0%, P<0.001), ileus (1.1% vs 2.8%, P=0.007), and shorter postoperative length of stay (17 vs 20 d, P<0.001).
Results date posted
| 2024 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted the study using Japanese healthcare databases of Diagnostic Procedure Combination (DPC) data provided by Medical Data Vision Co. Ltd. (MDV, Tokyo, Japan). DPC is a classification that combines diagnostic and medical procedures with a per diem payment system in the national Japanese health insurance system, and approximately 1,700 hospitals (20% of all hospitals in Japan) are included under the DPC system. Of these hospitals, MDV collected data from approximately 400 facilities representing about 25% of the acute care hospitals in Japan. From the database, we identified patients who underwent distal pancreatectomy between April 2008 and May 2020. We defined the primary underlying disease for which the surgery was performed, using the ICD-10 codes (C250-259, D136, D137, D377, K86) from the database of the primary diseases, underlying disease that triggered hospitalization, and the disease that required the most medical resources. We excluded patients whose information was incomplete (e.g., missing information about clinical cancer stage, body mass index, and smoking index).
Participant flow
We conducted the study using Japanese healthcare databases of Diagnostic Procedure Combination (DPC) data provided by Medical Data Vision Co. Ltd. (MDV, Tokyo, Japan). DPC is a classification that combines diagnostic and medical procedures with a per diem payment system in the national Japanese health insurance system, and approximately 1,700 hospitals (20% of all hospitals in Japan) are included under the DPC system. Of these hospitals, MDV collected data from approximately 400 facilities representing about 25% of the acute care hospitals in Japan. From the database, we identified patients who underwent distal pancreatectomy between April 2008 and May 2020. We defined the primary underlying disease for which the surgery was performed, using the ICD-10 codes (C250-259, D136, D137, D377, K86) from the database of the primary diseases, underlying disease that triggered hospitalization, and the disease that required the most medical resources. We excluded patients whose information was incomplete (e.g., missing information about clinical cancer stage, body mass index, and smoking index).
Adverse events
None in particular.
Outcome measures
Patient outcomes included in-hospital mortality, morbidity, postoperative length of stay, reoperation during the period of admission, 30-day readmission after discharge, and medical cost. Morbidities included postoperative pancreatic fistula (POPF) (K868), post-pancreatectomy hemorrhage (PPH) (K661, R58, T810, T811), surgical-site infection (SSI) (T793, T814, T813, T941), peritoneal abscess (K65), ileus and bowel obstruction (K560, K562, K565-567, K913), respiratory failure (J12-18, J690, J691, J958, J959, J96), pulmonary embolism (I26), acute coronary syndrome (I21-25), stroke (I60-66), acute renal failure (N17), urinary tract infection (N10, N30, N390), and sepsis (A021, A227, A241, A267, A282, A327, A394, A40, A41, A548, B007, B349, B377).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study using a commercial database
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052290
