Pancreatic CarcinomaNCT06763250
In This Study, a Retrospective Analysis Was Conducted to Explore the Risk Factors for Patients Undergoing Pancreaticoduodenal Surgery (PD) to Achieve TO, and a Nomogram Prediction Model Was Further Established to Promote the Standardization and Standardization of PD Surgical Quality Evaluation.
An observational study of Pancreatic Carcinoma and Cholangiocarcinoma, run by luokai zhang at 1 site in China.
Trial summary
This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pancreatic Carcinoma, Cholangiocarcinoma, Pancreaticoduodenectomy
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From the 260 specimens collected so far in this study, we obtained the description of the study population. In terms of age, 6.53% of the samples were less than 50 years old, 13.84% were more than or equal to 50 years old and 60 years old, 46.54% were more than or equal to 60 years old and 70 years old, 29.23% were more than or equal to 70 years old and 3.86% were more than or equal to 80 years old. In terms of gender, 57.31% of the sample were male and 42.69% were female. All the samples in this study were Han. 98.85% of the sample were married. The population samples for this study were all from the Second People\'s Hospital of Changzhou City.The risk factors affecting the textbook outcome of PD surgery in this study population were: 1. Diabetes; 2. Preoperative bile duct inflammation; 3. Intraoperative pancreatic duct diameter; 4; Vascular invasion; 5. Duration of operation; 6. Surgical method.
Who may be able to join
- Patients who received radical PD surgery and whose pathological findings were clear tumors;
- Complete clinical data preservation.
Who cannot join
- 1. Palliative resection; 2. Tumor metastasis or other primary tumors; 3. Combined with severe organ dysfunction; 4. Postoperative pathology was not clear tumor.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second People's Hospital of Changzhou, Jiangsu Province, China
Changzhou, Jiangsu, 213000
zhunfu zhu, PhD, 13961190702, zcfmlm@njmu.edu.cn
About this study
Official title: Risk Factors Influencing Textbook Outcomes in PD Surgery-a Single-center Analysis
This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
Read the detailed description
As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the \"surgical ceiling\", but because of its high postoperative complication rate and poor prognosis, a standardized surgical quality assessment system covering the whole perioperative period is urgently needed. The concept of the textbook ending was born.it first appeared in a 2013 study by Kolfschoten et al for colorectal cancer, in which textbook outcomes were evaluated in an all or none ,manner against six independent expected outcome measures: There were no deaths in hospital or within 30 days after surgery, radical resection, no re-intervention, no stomy, no serious postoperative complications, and no prolonged hospital stay. That is, when patients meet the above six indicators at the same time, they are defined as achieving a textbook outcome .In our study, the textbook outcome is the primary outcome, and the reverse is the secondary outcome.This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
- Keywords
- textbook outcome, pancreatic carcinoma, cholangiocarcinoma, pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma
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 |
|---|---|---|
| We divided the clinical data into a TO group and a non-TO group through retrospective analysis | A textbook outcome (TO) of pancreatic surgery based on an international expert consensus, No postoperative hemorrhage of grade B/C, no postoperative pancreatic fistula of grade B/C, no biliary leakage of grade B/C, Clavien-Dindo complication grade < Ⅲ, no death during hospitalization or within 30 days after surgery, and no re-admission within 30 days after discharge were integrated as a comprehensive index. It can reflect the ideal surgical outcome. We divided the clinical data into a TO group and a non-TO group through retrospective analysis. In order to promote the standardization and standardization of PD surgical quality assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve TO as the main ending
We expected TO collect 280 PD surgery patients, 262 cases have been collected, of which 158 cases achieved TO as the main outcome, the TO rate is 60.31%.
Measured: from January 2016 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2024
- Study completion31 Dec 2024 (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 Pancreatic CarcinomaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- luokai zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, luokai zhang, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763250
- Sponsor's protocol ID
- CN CZEY
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma L, Wu S, Cheng Y, Gao Y, Fan J, Zhu C. Laparoscopic duodenum-preserving total pancreatic head resection for benign and low-grade malignant tumors close to the accessory papilla (a case series). Surg Endosc. 2026 Jan;40(1):434-445. doi: 10.1007/s00464-025-12236-9. Epub 2025 Oct 23.
PubMed 41128852
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Influencing Textbook Outcomes in PD Surgery-a Single-center Analysis
- ClinicalTrials.gov ID
- NCT06763250
- Acronym / sponsor ID
- CN CZEY
- Keywords
- textbook outcome, pancreatic carcinoma, cholangiocarcinoma, pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- luokai zhangUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jan 2025 (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 study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
Detailed description
As we all know, pancreaticoduodenectomy (whipple) involving multiple organ reconstruction for pancreatic cancer is known as the \"surgical ceiling\", but because of its high postoperative complication rate and poor prognosis, a standardized surgical quality assessment system covering the whole perioperative period is urgently needed. The concept of the textbook ending was born.it first appeared in a 2013 study by Kolfschoten et al for colorectal cancer, in which textbook outcomes were evaluated in an all or none ,manner against six independent expected outcome measures: There were no deaths in hospital or within 30 days after surgery, radical resection, no re-intervention, no stomy, no serious postoperative complications, and no prolonged hospital stay. That is, when patients meet the above six indicators at the same time, they are defined as achieving a textbook outcome .In our study, the textbook outcome is the primary outcome, and the reverse is the secondary outcome.This study is committed TO exploring the risk factors affecting patients receiving pancreaticoduodenal surgery (PD) to achieve TO by retrospective analysis of clinical data of patients receiving PD surgery in Changzhou Second People Hospital from January 2016 to December 2024, and further establishing a nomogram prediction model. In order to promote the standardization and standardization of PD surgical quality assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| We divided the clinical data into a TO group and a non-TO group through retrospective analysis | – | –A textbook outcome (TO) of pancreatic surgery based on an international expert consensus, No postoperative hemorrhage of grade B/C, no postoperative pancreatic fistula of grade B/C, no biliary leakage of grade B/C, Clavien-Dindo complication grade < Ⅲ, no death during hospitalization or within 30 days after surgery, and no re-admission within 30 days after discharge were integrated as a comprehensive index. It can reflect the ideal surgical outcome. We divided the clinical data into a TO group and a non-TO group through retrospective analysis. In order to promote the standardization and standardization of PD surgical quality assessment. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From the 260 specimens collected so far in this study, we obtained the description of the study population. In terms of age, 6.53% of the samples were less than 50 years old, 13.84% were more than or equal to 50 years old and 60 years old, 46.54% were more than or equal to 60 years old and 70 years old, 29.23% were more than or equal to 70 years old and 3.86% were more than or equal to 80 years old. In terms of gender, 57.31% of the sample were male and 42.69% were female. All the samples in this study were Han. 98.85% of the sample were married. The population samples for this study were all from the Second People\'s Hospital of Changzhou City.The risk factors affecting the textbook outcome of PD surgery in this study population were: 1. Diabetes; 2. Preoperative bile duct inflammation; 3. Intraoperative pancreatic duct diameter; 4; Vascular invasion; 5. Duration of operation; 6. Surgical method.
Key inclusion criteria (2 listed)
- Patients who received radical PD surgery and whose pathological findings were clear tumors;
- Complete clinical data preservation.
Key exclusion criteria (2 listed)
- 1. Palliative resection; 2. Tumor metastasis or other primary tumors; 3. Combined with severe organ dysfunction; 4. Postoperative pathology was not clear tumor.
- -
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
Achieve TO as the main ending
Time frame: from January 2016 to August 2024
We expected TO collect 280 PD surgery patients, 262 cases have been collected, of which 158 cases achieved TO as the main outcome, the TO rate is 60.31%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 41128852Ma L, Wu S, Cheng Y, Gao Y, Fan J, Zhu C. Laparoscopic duodenum-preserving total pancreatic head resection for benign and low-grade malignant tumors close to the accessory papilla (a case series). Surg Endosc. 2026 Jan;40(1):434-445. doi: 10.1007/s00464-025-12236-9. Epub 2025 Oct 23.
- 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.
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 Carcinoma and Cholangiocarcinoma, run by luokai zhang 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: status not confirmed, as of the sponsor's last update on 8 Jan 2025. 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 Chunfu zhu, MD (13961190702, zcfmlm@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve TO as the main ending (time frame: from January 2016 to August 2024). 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 NCT06763250, 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 8 Jan 2025.