Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

Surgical Blood Loss Clinical Trial

Official title:

A Prospective Study of Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164769
• Other study ID #: 20220492
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Pancreatic Neoplasms
• Surgical Blood Loss

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

External Links

•   The aim of this study was to evaluate the postoperative clinical outcomes and long-term functional and oncologic results after pancreatic enucleation, and to compare the clinical results of laparoscopic and open enucleation.