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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06164769
Other study ID # 20220492
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 2026

Study information

Verified date December 2023
Source Zhejiang University
Contact Sheng Yan, professor
Phone +86-13957161680
Email shengyan@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility 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 Design


Intervention

Procedure:
blocking both the abdominal trunk and superior mesenteric artery in the 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.

Locations

Country Name City State
China the Second Affiliated Hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Song KB, Kim SC, Hwang DW, Lee JH, Lee DJ, Lee JW, Jun ES, Sin SH, Kim HE, Park KM, Lee YJ. Enucleation for benign or low-grade malignant lesions of the pancreas: Single-center experience with 65 consecutive patients. Surgery. 2015 Nov;158(5):1203-10. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary blood loss blockade of both the abdominal trunk and superior mesenteric artery changes the blood loss in the procedure
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