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

NCT06164769 | Recruiting

• 1 other identifier: 20220492
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor of Pancreas; Surgical Blood Loss

Keywords

Enucleation; pancreatic tumors; blood loss; the abdominal trunk; superior mesenteric artery

Outcome Measures

Primary Outcomes (1)

• blood loss

  blockade of both the abdominal trunk and superior mesenteric artery changes the blood loss

  in the procedure

Study Arms (1)

blockade of arteries in laparoscopic pancreatic enucleation

EXPERIMENTAL

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.

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

Interventions

blocking both the abdominal trunk and superior mesenteric artery in the pancreatic enucleation PROCEDURE

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.

blockade of arteries in laparoscopic pancreatic enucleation

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Highly malignant pancreatic tumors, or tumors with infiltration or metastasis
• Tumors of the body and tail of the pancreas
• Transfer to LPD or laparotomy

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related 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: 10.1016/j.surg.2014.10.008. Epub 2014 Nov 3.

  PMID: 25633730 BACKGROUND

Related 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.

MeSH Terms

Conditions

Pancreatic Neoplasms; Blood Loss, Surgical; Hemorrhage

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Bo Zhou, Dr.

  The Second Affiliated Hospital, Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Yan, professor

CONTACT

+86-13957161680; shengyan@zju.edu.cn

Bo Zhou, Dr.

CONTACT

+86-13758229594; zjuzhoubo@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Hepatology and Pancreatology, Principal Investigator, Clinical Professor.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will become available in June 2026 and for 6 months.
• Access Criteria: The IPD in the current study are available from central contact person upon reasonable request.

Locations

CN (1)