Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Histotripsy is a non-thermal, mechanical process of focused ultrasound used to mechanically destroy targeted soft tissue.

HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy

Zoe Secord

The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.

This is a prospective multi-center, single-arm, feasibility trial designed to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinoma tumors in patients who are diagnosed with unresectable locally advanced (Stage 3) or oligometastatic disease (Stage 4).

The type of design is exploratory and is considered interventional. Following histotripsy, subjects will undergo imaging ≤36-hours post-index procedure. Additionally, subjects will be followed at 7-day, 14-day, 30-day, 60-day, 120-day, and 180-day timepoints.

Prospective multi-center, single-arm, feasibility trial.

The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy

Index procedure-related complications ≤30 days post index procedure, graded using Clavien-Dindo Classification and Common Terminology Criteria for Adverse Events (CTCAE). \[Clinical Events Committee Adjudicated\]

HistoSonics, Inc.

Symptoms and General Pathology

Hemorrhage

Blood Loss, Surgical

Intraoperative Complications

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.

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

Sheng Yan, professor

Bo Zhou, Dr.

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.

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.

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

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

The IPD in the current study are available from central contact person upon reasonable request.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy	NCT06282809	Pancreas Cancer Adenocarcinoma ... Pancreatic Canc... Tumor of Pancre...	HistoSonics Edi...	18 Years -	HistoSonics, Inc.
Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery	NCT06164769	Tumor of Pancre... Surgical Blood ...	blocking both t...	14 Years - 70 Years	Zhejiang University

Spots Global Cancer Trial Database for tumor of pancreas