Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

Gastrointestinal Cancer Clinical Trial

— APPEAL-GC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862378
• Other study ID #: 2016YJZ32
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2019
• Source: Peking University
• Contact: Zhouqiao Wu, MD PhD
• Phone: 0086-10-88196606
• Email: wuzhouqiao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned surgery for gastric or colorectal cancer with primary anastomosis.

• Inform consent signed before surgery.

Exclusion Criteria:

• No drainage tube placed.

Related Conditions & MeSH terms

• Anastomotic Leak
• Complication
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Inflammatory Response
• Intraabdominal Infections

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.