Clinical trial NCT06164769: Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery
Official title: A Prospective Study of Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor of Pancreas
Surgical Blood Loss
Keywords: Enucleation
pancreatic tumors
blood loss
the abdominal trunk
superior mesenteric artery
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood loss
timeFrame: in the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital, Zhejiang Chinese Medical University
name: Bo Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1016/j.surg.2014.10.008. Epub 2014 Nov 3.