Operative Risk After Pancreatic Surgery in Patients With End Stage Renal Disease

February 25, 2026 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

The Analysis of End-stage Renal Disease for Outcomes in Pancreatic Surgery

End-stage renal disease (ESRD) patients often present risk factors for many surgical complications. The severity of renal failure and whether the patient is receiving renal replacement therapy are also related to the difficulty of pancreatic and other major surgeries, causing many ESRD patients to hesitate when choosing surgery. Therefore, this project aims to retrospectively collect basic data, preoperative and postoperative blood tests (blood cell counts, biochemistry, tumor markers, glucose-related, lipid-related), and preoperative and postoperative imaging examinations (CT, MRI, Ultrasound, PET scan, Endoscopy, etc.) of ESRD patients who underwent pancreatic surgery at our hospital.the investigators aim to compare whether surgical methods, severity of renal failure, use of renal replacement therapy, and lesion margin clearance rates affect the occurrence of surgical complications, length of hospital stay, length of ICU stay, re-operation rates or severe complications, medical costs, and related quality of life. This analysis is intended to understand and analyze the surgical prognosis, care priorities, common complications, and the management and outcomes of our team for ESRD patients undergoing pancreatic surgery, with the expectation of providing more diverse and specific treatment recommendations for these patients in the future.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background End-stage renal disease patients often present risk factors for many surgical complications. However, the severity of renal failure and whether the patient is receiving renal replacement therapy are also related to the difficulty of pancreatic and other major surgeries, causing many end-stage renal disease patients to hesitate when choosing surgery options.

IV. Objectives To compare whether surgical methods, severity of renal failure, use of renal replacement therapy, and lesion margin clearance rates affect the patient's occurrence of surgical complications, length of hospital stay, length of ICU stay, re-operation or severe complications, medical costs, and related quality of life.

V. Methodology and Procedures Data Collection The Principal Investigator and Co-Investigator will retrospectively review medical records to collect basic data of patients with end-stage renal disease who underwent pancreatic surgery at this hospital. This includes preoperative and postoperative blood tests (blood counts, biochemistry, tumor markers, glucose-related, lipid-related) and imaging examinations (CT, MRI, Ultrasound, PET scan, Endoscopy, etc.). This data will be used to compare the impact of surgical methods, renal failure severity, renal replacement therapy status, and margin clearance on surgical complications, hospital stay, ICU stay, re-operations, severe complications, medical costs, and quality of life. The goal is to analyze the prognosis, care priorities, and management outcomes for ESRD patients undergoing pancreatic surgery.

From the hospital portal system, approximately 500 medical records of patients with pancreatic diseases who underwent pancreatic surgery or invasive treatment performed by the Principal Investigator and Co-Investigator between January 2005 and July 2021 will be collected. This observational study will collect routine imaging and laboratory tests performed at the hospital to analyze treatment indications, surgical indicators, and prognosis.

Inclusion Criteria:

  1. Males or females aged 20 years or older.
  2. Patients scheduled to undergo pancreatic surgery.

Exclusion Criteria:

  1. Patients under 20 years of age at this hospital.
  2. Presence of other active malignancies prior to diagnosis.
  3. Minors, pregnant women, breastfeeding women, and patients with psychiatric disorders.

Treatment Flow For patients after pancreatic surgery, daily records will be kept regarding vital signs, drainage volume, intake/output balance, dietary intake and emptying, occurrence/management/severity of complications, length of hospital stay, length of ICU stay, re-operations or severe complications, medical costs, related quality of life, and nutritional status. Additionally, CT, MRI, endoscopy, and upper GI series examinations may be used to track and assist in analyzing the causes of postoperative complications.

Statistical Analysis The study will analyze the surgical prognosis, care priorities, common complications, and the management and outcomes of the hospital team for ESRD patients undergoing pancreatic surgery, aiming to provide diverse and specific treatment recommendations in the future.

Confidentiality and Privacy Protection To ensure patient privacy and personal information security, after querying the relevant data of enrolled subjects, the data sheet will use new codes to represent the subjects' identities. Experimenters and analysts will only have access to this de-linked data sheet for analysis. All electronic data will be password-protected and accessible only by specific personnel related to this project.

All data not used or after analysis will be stored at the NTU Department of Surgery for 15 years and then destroyed by shredder or incineration to remove identifiable personal data, unless required for medical or research purposes. Researchers (including external personnel) will sign a written pledge stating that medical record data will not be reused, disclosed to third parties, or used for purposes outside this study, unless required by law or audited by the Research Ethics Committee. If researchers encounter data that cannot directly identify identity, they will not attempt to identify individual patients. Collaborating external academic institutions or manufacturers must sign a research collaboration agreement.

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with end-stage renal disease and need pancreatic surgery

Description

Inclusion Criteria:

  • Males or females aged between 20 and 75 years.
  • Patients scheduled to undergo pancreatic surgery.

Exclusion Criteria:

  • Patients under 20 or over 75 years of age at this hospital.
  • Presence of other active malignancies prior to diagnosis.
  • Minors, pregnant women, breastfeeding women, and patients with psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinically relevant POPF and Clavian Dindo IIIA or higher complication
Time Frame: within 6 months after operation
within 6 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202107127RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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