- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06164769
Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery
May 27, 2025 updated by: Sheng Yan, Zhejiang University
A Prospective Study of Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery
Pancreatic enucleation could preserve more healthy pancreatic tissues and functions with a low recurrence risk.
However, conventional enucleation can cause significant intraoperative bleeding, especially in which tumors in the pancreatic head, neck, and uncinate process of pancreas, as these tissues are rich in blood supply, mainly including the abdominal trunk and the superior mesenteric artery.
In this study, we developed a novel method to control the pancreatic blood flow in laparoscopic enucleation--blocking the abdominal trunk and superior mesenteric artery with vascular occlusion clips in the process of resection, and evaluated its effectiveness and safety.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Between March 2023 and May 2026, patients who underwent laparoscopic pancreatic enucleation by blocking both the abdominal trunk and superior mesenteric artery in the Second Affiliated Hospital of Zhejiang University would be included in our prospective study.
Inclusion criteria: 1) benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis;.2) tumors sited in the pancreatic head, neck, and uncinate process of pancreas; 3) blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation.
Exclusion criteria:1) highly malignant pancreatic tumors, or tumors with infiltration or metastasis; 2) tumors of the body and tail of the pancreas;3) transfer to LPD or laparotomy.
Patient characteristic including clinical, biochemical and radiological data will be recorded and analyzed.
All patients will provide written informed consent before inclusion.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sheng Yan, professor
- Phone Number: +86-13957161680
- Email: shengyan@zju.edu.cn
Study Contact Backup
- Name: Bo Zhou, Dr.
- Phone Number: +86-13758229594
- Email: zjuzhoubo@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University
-
Contact:
- Sheng Yan, professor
- Phone Number: +86-13957161680
- Email: shengyan@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis
- Tumors sited in the pancreatic head, neck, and uncinate process of pancreas
- Blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation
Exclusion Criteria:
- Highly malignant pancreatic tumors, or tumors with infiltration or metastasis
- Tumors of the body and tail of the pancreas
- Transfer to LPD or laparotomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: blockade of arteries in laparoscopic pancreatic enucleation
In the pancreatic enucleation, Kocher Maneuver was routinely performed at first.
Then free the left side of the abdominal trunk and superior mesenteric artery, loose tissues easy to free.After Kocher Maneuver and other surgical procedures, the abdominal trunk and superior mesenteric artery exposed.
Before resection of pancreatic tumors, a vascular occlusion clamp clip was used to block the root of both the abdominal trunk and superior mesenteric artery to control the pancreatic blood flow.
|
In the pancreatic enucleation, Kocher Maneuver was routinely performed at first.
Then free the left side of the abdominal trunk and superior mesenteric artery, loose tissues easy to free.After Kocher Maneuver and other surgical procedures, the abdominal trunk and superior mesenteric artery exposed.
Before resection of pancreatic tumors, a vascular occlusion clamp clip was used to block the root of both the abdominal trunk and superior mesenteric artery to control the pancreatic blood flow.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood loss
Time Frame: in the procedure
|
blockade of both the abdominal trunk and superior mesenteric artery changes the blood loss
|
in the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Zhou, Dr., The Second Affiliated Hospital, Zhejiang Chinese Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
December 1, 2023
First Submitted That Met QC Criteria
December 1, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Actual)
June 2, 2025
Last Update Submitted That Met QC Criteria
May 27, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The IPD in the current study are available from central contact person upon reasonable request.
IPD Sharing Time Frame
The data will become available in June 2026 and for 6 months.
IPD Sharing Access Criteria
The IPD in the current study are available from central contact person upon reasonable request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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