ComplicationAPPEAL-GCNCT03862378
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis
An observational study of Complication and Anastomotic Leak, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication, Anastomotic Leak, Intraabdominal Infections
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Planned surgery for gastric or colorectal cancer with primary anastomosis.
- Inform consent signed before surgery.
Who cannot join
- No drainage tube placed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Zhouqiao Wu, M.D., 86-010-8819-6606, shanfei@hsc.pku.edu.cn
Ziyu Li, M.D., 86-010-8819-6605, ziyu_li@hsc.pku.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Complication, Anastomotic Leak, Intraabdominal Infections, Inflammatory Response, Gastrointestinal Cancer
- Medical subject headings
- Anastomotic Leak, Intraabdominal Infections, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery until discharge, up to 90 days.
Secondary outcomes (2)
Abdominal infection rate.
Number of anastomotic leak and other abdominal infection patients divided by the total inclusions.
Measured: 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.
Measured: From surgery until discharge, up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University
- Investigators
- Ziyu Li, MD PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862378
- Sponsor's protocol ID
- 2016YJZ32
- Acronym
- APPEAL-GC
- Status last verified
- Jun 2019
- First submitted
- 31 Jan 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03862378
- Acronym / sponsor ID
- APPEAL-GC / 2016YJZ32
- Conditions
- Complication, Anastomotic Leak, Intraabdominal Infections, Inflammatory Response, Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Planned surgery for gastric or colorectal cancer with primary anastomosis.
- Inform consent signed before surgery.
Key exclusion criteria (1 listed)
- No drainage tube placed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive value of the nomogram prediction model (APPEAL-GC score)
Time frame: From surgery until discharge, up to 90 days.
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.
2 secondary outcomes
Abdominal infection rate.
Time frame: From surgery until discharge, up to 90 days.
Abdominal infection outcome.
Time frame: From surgery until discharge, up to 90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Complication
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziyu Li, MD PhD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication and Anastomotic Leak, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhouqiao Wu, MD PhD (0086-10-88196606, wuzhouqiao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of the nomogram prediction model (APPEAL-GC score) (time frame: From surgery until discharge, up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.