NCT07091097

Brief Summary

Background: Complete resection is the primary curative option for most non-metastatic solid malignancies. Locally advanced stages, involving adjacent organs or structures, may require multivisceral resection. This study aims to comprehensively assess outcomes and risk factors of multivisceral oncological resections involving the pancreas, enhance understanding, and provide clinical guidance. The potential establishment of an international study group, centered on multivisceral resections involving the pancreas, will be further pursued based on the insights derived from this study. Objective: The objective of this study is to evaluate the outcomes of multivisceral oncological resections involving the pancreas and identify predictive factors for morbidity/mortality as well as for overall and disease-free survival. Methods: This retrospective multicenter study involves centers on a global scale conducting multivisceral oncological resections involving the pancreas. Data will be collected retrospectively from January 1st, 2010 to December 31st, 2022. Eligible patients are those undergoing elective multivisceral oncological resections involving the pancreas. Patient and operation characteristics, perioperative therapies, outcomes, complications, resection margins, and survival are recorded. Statistical analysis includes appropriate tests and subgroup analyses for distinct tumor entities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Keywords

multivisceral resection, pancreatic malignancies, oncological resections, outcomes, risk factors.

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality after surgery

    90 Day

Study Arms (1)

Patients undergoing multivisceral pancreatic resections

Concerning pancreatic malignancies, multivisceral pancreatic resection refers to the excision of organs beyond the pancreas or spleen in cases of distal pancreatectomy (DP). For multivisceral pancreaticoduodenectomies or total pancreatectomies, the resection encompasses additional organs other than the distal two-thirds of the stomach, duodenum with the first jejunal loop, bile duct including the gallbladder, and spleen. It is important to note that additional procedures like portal vein resection or splenectomy are not categorized as multivisceral resections within the respective resection types. In cases involving non-pancreatic malignancies, any surgical procedure that includes resection of the pancreas along with other organs will be classified as a multivisceral resection. Notably, patients who underwent isolated pancreatic resection for pancreatic metastasis or revision pancreatectomies will be excluded from this analysis. P

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Concerning pancreatic malignancies, multivisceral pancreatic resection refers to the excision of organs beyond the pancreas or spleen in cases of distal pancreatectomy (DP). For multivisceral pancreaticoduodenectomies or total pancreatectomies, the resection encompasses additional organs other than the distal two-thirds of the stomach, duodenum with the first jejunal loop, bile duct including the gallbladder, and spleen. It is important to note that additional procedures like portal vein resection or splenectomy are not categorized as multivisceral resections within the respective resection types. In cases involving non-pancreatic malignancies, any surgical procedure that includes resection of the pancreas along with other organs will be classified as a multivisceral resection. Notably, patients who underwent isolated pancreatic resection for pancreatic metastasis or revision pancreatectomies will be excluded from this analysis. Patients who were not undergoing oncological resections (

Concerning pancreatic malignancies, multivisceral pancreatic resection refers to the excision of organs beyond the pancreas or spleen in cases of distal pancreatectomy (DP). For multivisceral pancreaticoduodenectomies or total pancreatectomies, the resection encompasses additional organs other than the distal two-thirds of the stomach, duodenum with the first jejunal loop, bile duct including the gallbladder, and spleen. It is important to note that additional procedures like portal vein resection or splenectomy are not categorized as multivisceral resections within the respective resection types. In cases involving non-pancreatic malignancies, any surgical procedure that includes resection of the pancreas along with other organs will be classified as a multivisceral resection. Notably, patients who underwent isolated pancreatic resection for pancreatic metastasis or revision pancreatectomies will be excluded from this analysis. Patients who were not undergoing oncological resections (e. g. traumatic lesions) or those who did not undergo surgery as "curative intent" will be also excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Uniklinikum Halle

Halle, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

January 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations