Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Communicable Diseases

Intraabdominal Infections

Anastomotic Leak

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Postoperative Complications

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

Zhouqiao Wu, MD PhD

Zhouqiao Wu, M.D.

Ziyu Li, M.D.

Jiafu Ji, M.D.

Ziyu Li, MD PhD

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.

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.

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.

Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

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

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.

Number of anastomotic leak and other abdominal infection patients divided by the total inclusions.

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.

Peking University

Professor

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Intestinal Diseases

Aneurysm

Vascular Diseases

Kidney Calculi

Nephrolithiasis

Calculi

Leiomyoma

Aortic Aneurysm

Myofibroma

Diverticulitis

Pregnancy, Ectopic

Pancreatitis

Gallstones

Cholelithiasis

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Ovarian Cysts

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Appendicitis

Cardiac Complexes, Premature

Abdominal Injuries

Pancreatic Diseases

Aortic Diseases

Gastroenteritis

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Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Male Urogenital Diseases

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Biliary Tract Diseases

Gallbladder Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Joshua Broder, MD

Summary

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis.
2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications

Wallace H. Coulter Foundation

Duke University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis	NCT03862378	Complication Anastomotic Lea... Intraabdominal ... Inflammatory Re... Gastrointestina...		18 Years -	Peking University
Point of Care 3D Ultrasound for Various Applications: A Pilot Study	NCT02831556	Appendicitis Evidence of Cho... Gallstones Pregnancy, Ecto... Aortic Aneurysm Kidney Stones Intrauterine Pr... Diverticulitis Abdominal Injur... Tumors Pancreatitis Digestive Syste... Gastrointestina... Intraabdominal ... Intestinal Dise... Pregnancy Vascular Diseas... Uterine Fibroid... Ovarian Cysts Uterine Abnomin... Bladder Abnomin... Testicular Abno... Polyps		-	Duke University

Spots Global Cancer Trial Database for intraabdominal infections