Pancreatic NeoplasmsNCT05616403
Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy
An observational study of Pancreatic Neoplasms, run by Tongji Hospital at 1 site in China.
Trial summary
This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms
- How many people
- 1,029 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2010to 15 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent laparoscopic pancreaticoduodenectomy from 16 high-volume pancreatic centers in China from January 2010 and August 2016.
Who may be able to join
- Patients underwent laparoscopic pancreaticoduodenectomy.
- Aged 18 to 75 years old.
Who cannot join
- Peritoneal seeding or metastasis to distant sites.
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study
This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook outcome and analyze hospital variations regarding the textbook outcome after case-mix adjustment.
Read the detailed description
Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in recent years. Traditionally, quality assessment of LPD has mainly focused on individual outcome measures such as morbidity, mortality, operative time, operative blood transfusion, readmission rates and length of hospital stay. However, individual outcome parameters do not reflect the multiple facets of the whole surgical procedure and do not measure actual variations among different hospitals. In this context, several outcome experts have suggested that composite measures of surgical quality may be better than individual outcome parameters to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal surgeons in order to give a comprehensive summary of hospital performance. TO is realized when all of the desired outcome parameters are achieved following surgery and represents the optimal ("textbook") hospitalization.
Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD are lacking, especially from China. The objective of this study was to assess TO among patients undergoing LPD in China, identify factors independently associated with achieving TO and analyze hospital variations regarding the TO after case-mix adjustment.
- Conditions
- Pancreatic Neoplasms
- Being tested
- No intervention
- Keywords
- textbook outcome, laparoscopic pancreaticoduodenectomy, composite outcome measure, hospital variation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Textbook outcome group | Achieving textbook outcome after laparoscopic pancreaticoduodenectomy Receives: Other: No intervention | |
| Non-Textbook outcome group | Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook outcome
Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade ≥ Ⅲ), in-hospital or 30-day mortality, and readmission within 30 days after discharge.
Measured: 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 posted15 Nov 2022
- Study start18 Jan 2010
- Primary completion28 Aug 2016
- Study completion15 Jan 2021
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 Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Retrospective
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The Second Hospital of Hebei Medical University, Hunan Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Chinese PLA General Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Xuzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing Medical University, The First Hospital of Jilin University, Zhejiang University, Huadong Hospital
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
- Investigators
- Renyi Qin, MD, Study director, Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616403
- Sponsor's protocol ID
- TJDBPS13
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Peng B, Liu J, Yin X, Tan Z, Liu R, Hong D, Zhao W, Wu H, Chen R, Li D, Huang H, Miao Y, Liu Y, Liang T, Wang W, Yuan J, Li S, Zhang H, Wang M, Qin R; Minimally Invasive Treatment Group in the Pancreatic DiseaseBranch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Textbook outcome as a composite outcome measure in laparoscopic pancreaticoduodenectomy: a multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):374-382. doi: 10.1097/JS9.0000000000000303.
PubMed 36912568
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT05616403
- Acronym / sponsor ID
- TJDBPS13
- Conditions
- Pancreatic Neoplasms
- Keywords
- textbook outcome, laparoscopic pancreaticoduodenectomy, composite outcome measure, hospital variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, The Second Hospital of Hebei Medical University, Hunan Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Chinese PLA General Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Xuzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing Medical University, The First Hospital of Jilin University, Zhejiang University, Huadong Hospital
- Study start
- 18 Jan 2010 (actual)
- Primary completion
- 28 Aug 2016 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 15 Nov 2022 (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.
This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook outcome and analyze hospital variations regarding the textbook outcome after case-mix adjustment.
Detailed description
Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in recent years. Traditionally, quality assessment of LPD has mainly focused on individual outcome measures such as morbidity, mortality, operative time, operative blood transfusion, readmission rates and length of hospital stay. However, individual outcome parameters do not reflect the multiple facets of the whole surgical procedure and do not measure actual variations among different hospitals. In this context, several outcome experts have suggested that composite measures of surgical quality may be better than individual outcome parameters to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal surgeons in order to give a comprehensive summary of hospital performance. TO is realized when all of the desired outcome parameters are achieved following surgery and represents the optimal ("textbook") hospitalization.
Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD are lacking, especially from China. The objective of this study was to assess TO among patients undergoing LPD in China, identify factors independently associated with achieving TO and analyze hospital variations regarding the TO after case-mix adjustment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Textbook outcome group | – | Other: No interventionAchieving textbook outcome after laparoscopic pancreaticoduodenectomy |
| Non-Textbook outcome group | – | Other: No interventionNot achieving textbook outcome after laparoscopic pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent laparoscopic pancreaticoduodenectomy from 16 high-volume pancreatic centers in China from January 2010 and August 2016.
Key inclusion criteria (2 listed)
- Patients underwent laparoscopic pancreaticoduodenectomy.
- Aged 18 to 75 years old.
Key exclusion criteria (2 listed)
- Peritoneal seeding or metastasis to distant sites.
- Incomplete clinical data
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 interventionThis is an observational study without any intervention | Other | Non-Textbook outcome group, Textbook outcome group |
Primary outcome
Textbook outcome
Time frame: up to 90 days
Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade ≥ Ⅲ), in-hospital or 30-day mortality, and readmission within 30 days after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 36912568Wu Y, Peng B, Liu J, Yin X, Tan Z, Liu R, Hong D, Zhao W, Wu H, Chen R, Li D, Huang H, Miao Y, Liu Y, Liang T, Wang W, Yuan J, Li S, Zhang H, Wang M, Qin R; Minimally Invasive Treatment Group in the Pancreatic DiseaseBranch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Textbook outcome as a composite outcome measure in laparoscopic pancreaticoduodenectomy: a multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):374-382. doi: 10.1097/JS9.0000000000000303.
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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.
Renyi Qin, MD study director
Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital
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 Pancreatic Neoplasms, run by Tongji Hospital 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 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: finished, as of the sponsor's last update on 15 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textbook outcome (time frame: up to 90 days). 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 NCT05616403, 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 15 Nov 2022.