Pancreatic Neoplasm of Uncertain Behavior HeadNCT05569343
Risk Factors for Achieving TO After LDPPHR-t
An observational study of Pancreatic Neoplasm of Uncertain Behavior Head, run by Tongji Hospital at 1 site in China.
Trial summary
This is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasm of Uncertain Behavior Head
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2020to 16 Apr 2022
- 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
- Adult, Older adult
Study population: Patients underwent laparoscopic duodenum-preserving total pancreatic head resection in the department of Biliary-Pancreatic Surgery of Tongji Hospital from May 2020 to December 2021.
Who may be able to join
- Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
- 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: Risk Factors for Achieving Textbook Outcome After Laparoscopic Duodenum-preserving Total Pancreatic Head Resection: a Retrospective, Observational Study
This is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.
Read the detailed description
Increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (CT), magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS). Laparoscopic duodenum-preserving total pancreatic head resection (LDPPHR-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. The evaluation of quality of LDPPHR-t is important for surgeons to improve surgical quality. Currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. These single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. Textbook outcome (TO) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. TO reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. However, the risk factors for achieving TO after LDPPHR-t is unknown and no relevant articles have been reported so far. The objective of study was to identify the risk factors for achieving TO after LDPPHR-t.
- Being tested
- No intervention
- Keywords
- Textbook outcome, Risk factors, Endoscopic nasobiliary drainage, Total pancreatic head resection, Duodenum-preserving, Laparoscopic
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 duodenum-preserving total pancreatic head resection Receives: Other: No intervention | |
| Non-Textbook outcome group | Not achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
The postoperative complications were graded into mild complications and severe complications according to the Clavien-Dindo classification of surgical complications, including postpancreatectomy hemorrhage, postoperative pancreatic fistula , and bile leakage.
Measured: up to 90 days
Secondary outcomes (3)
Operation time
Operation time defined as the time from skin incision or trocar placement to complete skin closure
Measured: Intraoperative
Intraoperative blood loss
Intraoperative blood loss recorded by the anesthetist using a vacuum system
Measured: Intraoperative
Readmission
Readmission defined as any readmission within 30 days after discharge
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start8 May 2020
- Primary completion23 Dec 2021
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neoplasm of Uncertain Behavior HeadStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT05569343
- Sponsor's protocol ID
- TJDBPS12
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Achieving Textbook Outcome After Laparoscopic Duodenum-preserving Total Pancreatic Head Resection: a Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT05569343
- Acronym / sponsor ID
- TJDBPS12
- Keywords
- Textbook outcome, Risk factors, Endoscopic nasobiliary drainage, Total pancreatic head resection, Duodenum-preserving, Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 6 Oct 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 single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.
Detailed description
Increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (CT), magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS). Laparoscopic duodenum-preserving total pancreatic head resection (LDPPHR-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. The evaluation of quality of LDPPHR-t is important for surgeons to improve surgical quality. Currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. These single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. Textbook outcome (TO) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. TO reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. However, the risk factors for achieving TO after LDPPHR-t is unknown and no relevant articles have been reported so far. The objective of study was to identify the risk factors for achieving TO after LDPPHR-t.
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 duodenum-preserving total pancreatic head resection |
| Non-Textbook outcome group | – | Other: No interventionNot achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent laparoscopic duodenum-preserving total pancreatic head resection in the department of Biliary-Pancreatic Surgery of Tongji Hospital from May 2020 to December 2021.
Key inclusion criteria (2 listed)
- Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
- 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
postoperative complications
Time frame: up to 90 days
The postoperative complications were graded into mild complications and severe complications according to the Clavien-Dindo classification of surgical complications, including postpancreatectomy hemorrhage, postoperative pancreatic fistula , and bile leakage.
3 secondary outcomes
Operation time
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Readmission
Time frame: up to 30 days
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 6 Oct 2022.
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 Neoplasm of Uncertain Behavior Head, 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 6 Oct 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?
postoperative complications (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?
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 6 Oct 2022.