ComplicationPACAGENCT03828266
Prediction of Abdominal Complications After GastroEnterological Surgery
An observational study of Complication and Anastomotic Leak, run by Peking University at 19 sites in China.
Trial summary
The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication, Anastomotic Leak, Gastrointestinal Cancer
- How many people
- 4,000 participants
- Where
- 19 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2020
- How long will I take part?
- 1 Month
- 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: All adult patients undergo gastrointestinal (GI) surgery for GI tumor.
Who may be able to join
- Planned gastrointestinal surgery.
- Inform consent received.
Who cannot join
- Endoscopic surgery.
- Inform consent denied.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Ziyu Li, M.D., ligregory369@hotmail.com
Zhouqiao Wu, M.D., wuzhouqiao@gmail.com
- Recruiting
Jilin University Second Hospital
Changchun, Jilin
Jiaming Zhu
- Not yet recruiting
Dalian Medical University First Hospital
Dalian, Liaoning
Pin Liang
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Zhaohui Zheng
- Not yet recruiting
Guangdong People's Hospital
Guangzhou, Guangdong
Yong Li
- Recruiting
The First Affilliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Wu Song, denisewei@126.com
- Recruiting
South Hospital
Guanzhou, Guangdong
Jiang Yu, balbc@163.com
- Recruiting
Hangzhou First Hospital
Hangzhou, Zhejiang
Jian Zhang
- Not yet recruiting
Run Run Shaw Hospital
Hangzhou, Zhejiang
Linghua Zhu
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Changqing Jing
- Recruiting
Nanchang University First Hospital
Nanchang, Jiangxi
Zhengrong Li
- Not yet recruiting
Qingdao University Affiliated Hospital
Qingdao, Shandong
Zhaojian Niu
- Not yet recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality
Hua Huang
- Not yet recruiting
Huashan Hospital
Shanghai, Shanghai Municipality
Hankun Hao
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Lu Zang
- Not yet recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality
Fenglin Liu
- Recruiting
Xi'an Jiao Tong University First Hospital
Xi’an, Shanxi
Lin Fan
- Not yet recruiting
Xiamen University First Hospital
Xiamen, Fujian
Jun You
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Su Yan, MD, yansu3598507@163.com
About this study
Official title: Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.
Read the detailed description
All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.
The detailed registered information includes:
- Basic and surgical information:
Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.
II. Postoperative information:
Primary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.
III. Abdominal Infection information:
Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.
- Conditions
- Complication, Anastomotic Leak, Gastrointestinal Cancer
- Being tested
- No intervention
- Medical subject headings
- Anastomotic Leak, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will undergo routine clinical practice. There is no additional intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Infection rate after gastrectomy.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
Measured: From surgery until discharge, up to 90 days.
Abdominal Infection rate after colorectal surgery.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
Measured: From surgery until discharge, up to 90 days.
Secondary outcomes (3)
Classification of Abdominal Infection after Surgery
Severity classification scored based on Clavien-Dindo score, it includes five different scales indicating different severity of the complication.
Measured: From surgery until discharge, up to 90 days.
Diagnosis time of Abdominal Complication
1-3 days after surgery; 4-7 days after surgery; >1wk after surgery
Measured: From surgery until discharge, up to 90 days.
Outcome of Abdominal Infection Treatment
Cured before discharge, not cured before discharge, death.
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 posted4 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 4,000 participants (estimated)
- Target duration
- 1 Month
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
- NCT03828266
- Sponsor's protocol ID
- 2018YJZ56
- Acronym
- PACAGE
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Z, Gu T, Wang X, Wei T, Shan F, Li Z, Ji J; PACAGE study group. Surgical quality and health utilization of gastric cancer surgery in China: a post hoc analysis of the Prevalence of Abdominal Complications After Gastroenterological Surgery study. BMJ Surg Interv Health Technol. 2025 Jul 15;7(1):e000332. doi: 10.1136/bmjsit-2024-000332. eCollection 2025.
PubMed 40671863
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Infectious Complications After Gastrointestinal Surgery in China: a Multi-centered Prospective Registry
- ClinicalTrials.gov ID
- NCT03828266
- Acronym / sponsor ID
- PACAGE / 2018YJZ56
- Conditions
- Complication, Anastomotic Leak, Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Feb 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.
The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.
Detailed description
All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.
The detailed registered information includes:
- Basic and surgical information:
Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.
II. Postoperative information:
Primary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.
III. Abdominal Infection information:
Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergo gastrointestinal (GI) surgery for GI tumor.
Key inclusion criteria (2 listed)
- Planned gastrointestinal surgery.
- Inform consent received.
Key exclusion criteria (2 listed)
- Endoscopic surgery.
- Inform consent denied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients will undergo routine clinical practice. There is no additional intervention. | Other | – |
Primary outcome
Abdominal Infection rate after gastrectomy.
Time frame: From surgery until discharge, up to 90 days.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
Abdominal Infection rate after colorectal surgery.
Time frame: From surgery until discharge, up to 90 days.
Abdominal Infection includes anastomotic leakage and other intra-abdominal infectious complications.
3 secondary outcomes
Classification of Abdominal Infection after Surgery
Time frame: From surgery until discharge, up to 90 days.
Diagnosis time of Abdominal Complication
Time frame: From surgery until discharge, up to 90 days.
Outcome of Abdominal Infection Treatment
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 4 Feb 2019.
- Derived from this study: PubMed 40671863Wu Z, Gu T, Wang X, Wei T, Shan F, Li Z, Ji J; PACAGE study group. Surgical quality and health utilization of gastric cancer surgery in China: a post hoc analysis of the Prevalence of Abdominal Complications After Gastroenterological Surgery study. BMJ Surg Interv Health Technol. 2025 Jul 15;7(1):e000332. doi: 10.1136/bmjsit-2024-000332. eCollection 2025.
- Individual participant dataSharing planned: No
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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
19 sites 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 19 sites 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 2 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Abdominal Infection rate after gastrectomy. (time frame: From surgery until discharge, up to 90 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828266, which also lists 1 linked publication.
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 4 Feb 2019.