Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis (APPEAL-GC)

Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Intraabdominal Infections; Inflammatory Response; Anastomotic Leak; Complication; Gastrointestinal Cancer

Detailed Description

Intra-abdominal infectious complications such as anastomotic leakage are the most feared but common complications after gastrointestinal surgery. In our previous study, a nomogram model was established to predict intra-abdominal 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. A predicting score (i.e. APPEAL-GC score) was created based on the model. In this study, validation of this score in predicting intra-abdominal complications is planned to be conducted in this prospective cohort study.

In this study, all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included. The clinical data and complication data will be prospectively collected; the discarded drainage fluid will be collected and analyzed afterward. No additional intervention will be applied.

The cytokine levels in the drainage fluid will be evaluated, and together with the clinical data, an APPEAL-GC score will be created for each patient. We will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery. The predictive value (clinical usefulness) of the score will be validated in this study.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zhouqiao Wu, MD PhD; Phone Number: 0086-10-88196606; Email: wuzhouqiao@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital & Institute
      • Contact: Ziyu Li, M.D.; Phone Number: 86-010-8819-6605; Email: ziyu_li@hsc.pku.edu.cn
      • Contact: Zhouqiao Wu, M.D.; Phone Number: 86-010-8819-6606; Email: shanfei@hsc.pku.edu.cn
      • Sub-Investigator: Zhouqiao Wu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No drainage tube placed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal infection rate.	Number of anastomotic leak and other abdominal infection patients divided by the total inclusions.	From surgery until discharge, up to 90 days.
Abdominal infection outcome.	It is categorized as cured, not cured at discharge, death. The doctor is required to select one option at patient discharge. Proportions of different outcomes will be compared.	From surgery until discharge, up to 90 days.

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Ziyu Li, MD PHD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 8, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Neoplasms; Neoplasms by Site; Postoperative Complications; Digestive System Neoplasms; Gastrointestinal Diseases; Intraabdominal Infections; Gastrointestinal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: 2016YJZ32

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