UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062337 |
|---|---|
| Receipt number | R000071334 |
| Scientific Title | Safety and Efficacy of Tubeless Protocol in Selected Cases Undergoing Retroperitoneal Laparoscopic Adrenal Tumor Resection |
| Date of disclosure of the study information | 2026/07/25 |
| Last modified on | 2026/07/25 18:43:42 |
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Basic information
Public title
Safety and efficacy of tubeless laparoscopic surgery for adrenal tumors
Acronym
Tubeless adrenal laparoscopic surgery study
Scientific Title
Safety and Efficacy of Tubeless Protocol in Selected Cases Undergoing Retroperitoneal Laparoscopic Adrenal Tumor Resection
Scientific Title:Acronym
Tubeless adrenal resection cohort study
Region
| Asia(except Japan) |
Condition
Condition
Benign adrenal tumors (non-functional adenoma, aldosteronoma, pheochromocytoma, myelolipoma) requiring retroperitoneal laparoscopic resection
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of stratified tubeless protocol versus routine drainage placement for retroperitoneal laparoscopic resection of benign adrenal tumors in a dual-center prospective observational cohort, by analyzing perioperative recovery indicators and complication rates. This study is Phase 1 of a two-stage tubeless adrenal research project under unified ethical approval.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative length of hospital stay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Arm1: Tubeless protocol: laparoscopic adrenal resection without drainage tube, standardized hemostasis and vascular clipping, postoperative CT review.
Arm2: Conventional drainage: laparoscopic adrenal resection with routine indwelling retroperitoneal drainage tube.
Interventions/Control_2
Arm1: Tubeless protocol: laparoscopic adrenal resection without drainage tube, standardized hemostasis and vascular clipping, postoperative CT review.
Arm2: Conventional drainage: laparoscopic adrenal resection with routine indwelling retroperitoneal drainage tube.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Unilateral benign adrenal tumor confirmed by preoperative imaging;
2. Receiving retroperitoneal laparoscopic adrenal tumor resection via 3-port or 4-port approach;
3. Complete written informed consent obtained;
4. For tubeless group participants, all the following nine low-risk criteria must be fully satisfied:
(1) Age less than 61 years;
(2) Maximum tumor diameter less than 3.0 cm;
(3) Adrenal parenchyma and central adrenal vein occluded with locking clips;
(4) No surgical field adhesion or fat saponification;
(5) Intraoperative blood loss less than 80 mL;
(6) No intraoperative injury to peritoneum, kidney or other adjacent organs;
(7) Thorough intraoperative hemostasis without obvious wound exudation;
(8) No bleeding along trocar puncture tracts;
(9) No postoperative anticoagulant administration within 12 hours after surgery.
Patients who do not meet all nine tubeless criteria will be allocated to the conventional drainage group.
Key exclusion criteria
1. Preexisting coagulation disorders;
2. Oral anticoagulant medication taken within one week before surgery;
3. Cognitive dysfunction, communication disorders or severe psychiatric disorders unable to cooperate with treatment and follow-up;
4. Severe vital organ insufficiency or advanced systemic disease incompatible with general anesthesia;
5. Bilateral adrenal tumors;
6. Conversion to open surgery intraoperatively.
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Yan |
| Middle name | |
| Last name | Zhao |
Organization
Xuzhou Cancer Hospital
Division name
Xuzhou Cancer Hospital, Department of Urology
Zip code
221000
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
TEL
+8615996959302
529735655@qq.com
Public contact
Name of contact person
| 1st name | Ya |
| Middle name | Sheng |
| Last name | Cao |
Organization
Xuzhou Cancer Hospital
Division name
Department of Science and Education
Zip code
221000
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
TEL
+8619105168987
Homepage URL
xzsykjk@163.com
Sponsor or person
Institute
Xuzhou Cancer Hospital
Institute
Department
Personal name
Funding Source
Organization
the XZHMU-QL Joint Research Fund (QL-YB030) and the Xuzhou New Round of "Pengcheng Talent Program" High-level Health Talent Introduction and Training Project (2026GG006)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Xuzhou Cancer Hospital
Address
No.131 Huancheng Road, Gulou District, Xuzhou City, Jiangsu Province, P.R.China
Tel
+8619105168987
xzsykjk@163.com
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 | 07 | Month | 25 | 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
86
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
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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 | 07 | Month | 25 | Day |
Last modified on
| 2026 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071334
