Surgical Approach for Adenocarcinoma of the Pancreas With Synchronous Liver Metastases

NCT ID: NCT06980792

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-31

Brief Summary

The study focuses on patients with synchronous liver metastasis from pancreatic adenocarcinoma that underwent both pancreatic and liver resection. The control group is made up of patients with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that were excluded from surgery. Short and long-term outcomes will be compared to evaluate the safety and efficacy of simultaneous liver and pancreatic resection.

Detailed Description

1. Summary:

The study focuses on patients with synchronous liver metastasis from pancreatic adenocarcinoma that underwent both pancreatic and liver resection. The control group is made up of patients with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that were excluded from surgery. Short and long-term outcomes will be compared to evaluate the safety and efficacy of simultaneous liver and pancreatic resection.

2. Introduction 2.1 Background and rationale The most common pathological pattern of pancreatic tumor is pancreatic ductal adenocarcinoma (PDAC), which accounts for approximately 90% of all cases. For digestive tract tumors such as colorectal, gastric, and pancreatic tumors, distant metastases often represent the last stage of the disease evolvement, and liver is a frequent disseminate site for metastatic tumor. Among them, only hepatic resection for metastatic disease has gained general acceptance as a potentially curative option in patients with colorectal cancer. The role of surgery for metastases from neuroendocrine tumors on long-term outcome is also well-documented. Recently, Markar et al. reported that surgical resection of hepatic metastases from gastric adenocarcinoma was associated with a significantly improved overall survival (p < 0.001). Moreover, they confirmed the additional survival benefit of solitary compared with multiple hepatic metastases (odds ratio = 0.31; p = 0.011). Liver resection showed longer survival rates also for pancreatic neuroendocrine tumor (PNET) patients.

However, historical results regarding hepatic resection for PDAC were in conflicts and remained controversial. Furthermore, rare systematic review or meta-analysis was ever reported focusing on PDAC as a separate group. A recent meta-analysis reported that overall survival of PDAC patients can benefit from hepatic resection to some extent. It has been also recently showed that that surgical resection of pancreatic cancer with synchronous liver oligometastases is safe, and it can be associated with improved survival, providing a careful selection of patients after primary chemotherapy. Since a randomized controlled trial may be ethically questionable, a multicenter international retrospective study may clarify the role of liver resection in this cohort of patients.

2.2 Objectives

The primary aim is to examine recurrence free survival (RFS) and overall survival (OS) following surgical resection of synchronous hepatic metastases from PDAC, and to study the role of tumor burden and chemotherapy regimen on survival.

3. Methods:

3.1 Study design Patients underwent liver resection for synchronous metastases from pancreatic adenocarcinoma, single or multiple metastasis, will be included in the study, without any time interval limitation.

Clinical features, operative data and chemotherapy regimens will be analyzed. A control group of non-surgical patients will be included in the study for a propensity score match.

3.2 Setting

• No time interval limitation for recruitment
• No volume-based restriction for center eligibility 3.3 Participants Patients of age >18, underwent surgery for pancreatic adenocarcinoma (duodenopancreatectomy, distal pancreatectomy, total pancreatectomy) and liver resection (major or minor) for synchronous metastasis, that received neoadjuvant and/or adjuvant chemotherapy. The control group is made up of patients age >18 with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that didn't underwent surgery.

Conditions

Pancreas Neoplasms; Liver Metastasis; Pancreas Ductal Adenocarcinoma; Surgery of the Pancreatic Head; Liver Resection; Pancreatectomy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Surgical group

Patients that underwent pancreatic and liver surgery

Pancreatectomy and liver resection

Intervention Type: PROCEDURE

Surgery for synchronous liver metastasis from PDAC with or without previous neoadjuvant chemotherapy

Non-surgical group

Patients that underwent CHT alone

Chemotherapy

Intervention Type: DRUG

Chemotherapy alone in potentially resectable patients with PDAC and synchronous liver metastasis

Interventions

Pancreatectomy and liver resection

Surgery for synchronous liver metastasis from PDAC with or without previous neoadjuvant chemotherapy

Intervention Type: PROCEDURE

Chemotherapy

Chemotherapy alone in potentially resectable patients with PDAC and synchronous liver metastasis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients of age >18, underwent surgery for pancreatic adenocarcinoma (duodenopancreatectomy, distal pancreatectomy, total pancreatectomy) and liver resection (major or minor) for synchronous metastasis, that received neoadjuvant and/or adjuvant chemotherapy.
• The control group is made up of patients age >18 with resectable or borderline resectable pancreatic adenocarcinoma and synchronous liver metastasis that didn't underwent surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role: lead

Responsible Party

Fabrizio Di Benedetto

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU di Modena

Modena, , Italy

Countries

Italy

Other Identifiers

ISLS pancreas study group

Identifier Type: OTHER

Identifier Source: secondary_id

396/2021/OSS/AOUMO

Identifier Type: -

Identifier Source: org_study_id