NCT05128890

Brief Summary

The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint. The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
431

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2016Apr 2027

Study Start

First participant enrolled

April 16, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

August 12, 2019

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Patient Survival

    It will be calculated in days.Minimally invasive techniques are being adopted for complex pancreatic and liver surgery and there is a need to understand if these techniques are advantageous to the patient, if the cost is justified and if the risks are acceptable when compared to the gold standard open surgery.

    through study completion, an average of 1 year

  • Length of stay

    It will be calculated in days. The days stayed in hospital post-procedure.

    Up to 1 year

  • Complication rates

    Patient may visit physician or hospital for any symptoms or may need hospitalizations.

    through study completion, an average of 1 year

  • Operative time

    The time required for the procedure.

    up to 10 hours

  • Transfusion rate

    If any post-procedure transfusion required, will be recorded.

    through study completion, an average of 1 year

  • 30 and 90 day readmission rate

    After the procedure any hospital admissions up to 30 days will be recorded.

    through study completion, an average of 1 year

  • Hospital charges

    The hospital charges for the procedure will be recorded.

    through study completion, an average of 1 year

Interventions

to compare open versus minimally invasive pancreatic resection techniques and analyze the different outcome variables from the clinical standpoint

Also known as: minimally invasive pancreatic resection techniques

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)

You may qualify if:

  • Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
  • Patients 18 years old or older

You may not qualify if:

  • Patients that have not undergone pancreatic resection surgeries
  • Patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularPancreatic Neoplasms

Interventions

Pancreatic Hormones

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Alejandro Mejia, M.D.

    The Liver Institute, Methodist Dallas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette N Ndjom, MS

CONTACT

Jennifer Kirchner

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

November 22, 2021

Study Start

April 16, 2016

Primary Completion (Estimated)

April 26, 2027

Study Completion (Estimated)

April 26, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations