Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

NCT03862378 | Unknown

• 1 other identifier: 2016YJZ32
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In our previous study, a nomogram model was established to predict intra-abdominal infectious complications after gastrointestinal surgery. This model was based on the clinical data and the drainage fluid cytokine levels, and it received an AUC \>0.9. In this study, validation of this nomogram is planned to be conducted in this prospective cohort study.

Conditions

Complication; Anastomotic Leak; Intraabdominal Infections; Inflammatory Response; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Predictive value of the nomogram prediction model (APPEAL-GC score)

  The positive predictive value of the APPEAL-GC score in predicting the intra-abdominal infectious complications. Intra-Abdominal infectious complications include anastomotic leakage and other abdominal infectious complications. The complication definitions are in accordance with the Chinese consensus of gastrointestinal complication diagnosis and registration. The APPEAL-GC score was derived from our recently finished study (unpublished). It includes evaluation of the surgical type (open or laparoscopic), resection range, age, and cytokine levels on the postoperative day 3. A score of each patient can be determined, and a pre-set cut-off value (unpublished data) was determined in our previous study based on the AUC analysis. In this study, each patient will be scored accordingly. The positive predictive value and negative predictive value of the cut-off value will be evaluated.

  From surgery until discharge, up to 90 days.

Secondary Outcomes (2)

• Abdominal infection rate.

  From surgery until discharge, up to 90 days.

• Abdominal infection outcome.

  From surgery until discharge, up to 90 days.

Study Arms (1)

Group One

All patients underwent gastric or colorectal cancer surgery in the participating centers will be included. Clinical data, drainage cytokine levels will be recorded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This observational study intends to include all patients undergoing gastric or colorectal cancer with primary anastomosis. Because drainage fluid analysis is necessary for the prediction model, patients without the tube will be excluded.

You may qualify if:

• Planned surgery for gastric or colorectal cancer with primary anastomosis.
• Inform consent signed before surgery.

You may not qualify if:

• No drainage tube placed.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this study, we will collect the discarded drainage fluid for each patient for further analysis. The samples will be collected and stored in -80 refrigerators until analysis. The candidate targets include IL-1, IL-6, IL-10, TNF-a, MMP2, MMP9.

MeSH Terms

Conditions

Anastomotic Leak; Intraabdominal Infections; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Ziyu Li, MD PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhouqiao Wu, MD PhD

CONTACT

0086-10-88196606; wuzhouqiao@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: March 5, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

CN (1)