UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061526 |
|---|---|
| Receipt number | R000070403 |
| Scientific Title | A prospective single-arm pilot study evaluating the safety of omitting prophylactic intra-abdominal drainage after pancreatoduodenectomy |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/11 19:08:06 |
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Basic information
Public title
Omission of prophylactic intra-abdominal drainage after pancreatoduodenectomy: a prospective pilot safety study of a no-drain strategy
Acronym
No-drain PD Study
Scientific Title
A prospective single-arm pilot study evaluating the safety of omitting prophylactic intra-abdominal drainage after pancreatoduodenectomy
Scientific Title:Acronym
PD No-Drain Safety Study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate the safety of a no-drain strategy, in which prophylactic intra-abdominal drainage is omitted, in low-risk patients undergoing pancreatoduodenectomy. The primary outcome is the rate of invasive intra-abdominal reintervention within 30 days after surgery, and serious postoperative complications will also be assessed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of invasive reintervention within 30 days after surgery
Invasive reintervention is defined as percutaneous drainage, reoperation, or interventional radiology performed for postoperative complications within 30 days after surgery.
Key secondary outcomes
ClavienDindo gradeIII or higher complications, positive ascites culture before abdominal closure, overall morbidity, 30-day mortality, CR-POPF, infectious complications, pleural effusion/ascites, reintervention-related outcomes, CT-related outcomes, postpancreatectomy hemorrhage, bile leakage, delayed gastric emptying, length of stay, antibiotic use, postoperative pain, and diuretic use.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In low-risk patients for postoperative pancreatic fistula, a no-drain strategy will be applied during pancreatoduodenectomy by omitting prophylactic intra-abdominal drainage. Postoperative management will follow a predefined safety protocol, including clinical assessment, laboratory tests, imaging when clinically indicated, and reintervention such as percutaneous drainage, interventional radiology, or reoperation when necessary.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 to 85 years at the time of informed consent
Patients with a main pancreatic duct diameter of 3 mm or greater on preoperative computed tomography
Patients judged intraoperatively to have a hard pancreatic texture by surgical palpation
Patients with an Acinar Score of 3 or greater at the pancreatic transection margin
Patients who have received sufficient explanation about the study, fully understood its contents, and provided written informed consent voluntarily
Key exclusion criteria
Patients with distant metastasis
Patients with an operative time exceeding 8.5 hours
Patients with intraoperative blood loss exceeding 500 mL
Patients requiring concomitant vascular resection
Patients undergoing pancreatoduodenectomy for diseases other than pancreatic cancer
Patients judged by the principal investigator or subinvestigators to be unsuitable for participation in the study
Eligible patients are defined as those who meet all inclusion criteria and do not meet any of the exclusion criteria listed above.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
s.irie.fo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Irie |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Hepatobiliary-Pancreatic Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
0338133111
Homepage URL
s.irie.fo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Akio Saiura
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
Institutional Review Board, Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
0338133111
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | 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 | 04 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070403
