PancreatoduodenectomyNCT05703581
Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
An observational study of Pancreatoduodenectomy and Periampullary Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Aim of the study : To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatoduodenectomy, Periampullary Carcinoma, Pancreatic Cancer
- What is being tested?
- TRIANGLE operation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Feb 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent undergo pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation
Who may be able to join
- Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation.
- Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery.
- Be able to comply with the research visit plan and other program requirements
Who cannot join
- Patients accompanied by other systemic malignancies.
- Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery.
- Pregnant and lactating women.
- Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai
Chongyi Jiang, M.D., jiangzhongyi9@sina.com
Jiahao Chen, M.S.
About this study
Aim of the study :
To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .
Read more
Methods :
Patients who underwent pancreatoduodenectomy or Distal Pancreatectomy between 01 September 2016 and 30 December 2022 will be included in this retrospective analysis. 3D reconstruction is performed with preoperative enhanced CT, then the region of "Heidelberg Triangle" is categorized . The operation is completed by the same operation team. According to the operation mode, patients were divided into TRIANGLE group and non-TRIANGLE group and And followed up until recurrence, death or missed.
Read the detailed description
The "Heidelberg Triangle" is an anatomical area composed of Common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV).
This area is considered to be the common site of recurrence after pancreatic surgery.
Recent studies have shown that TRIANGLE operation can improve the state of the cutting edge and has potential value in improving the prognosis. However, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after TRIANGLE operation are insufficient.
The aim of the present study is to evaluate the effect and safety of "Heidelberg Triangle" dissection combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .
- Being tested
- TRIANGLE operation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIANGLE operationProcedure or surgery
dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)
| Study group | Role | What they receive |
|---|---|---|
| PD(TRIANGLE) | Patients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy Receives: Procedure: TRIANGLE operation | |
| PD(non-TRIANGLE) | Patients with pancreatic head cancer or periampullary cancer underwent pancreatoduodenectomy with standard lymphadenectomy | |
| DP(TRIANGLE) | Patients with carcinoma of the body and tail of the pancreas underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with distal pancreatectomy and standard lymphadenectomy Receives: Procedure: TRIANGLE operation | |
| DP(non-TRIANGLE) | Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS)
from the date of surgery to the first radiographic or pathologic evidence of recurrence.
Measured: up to 72 months
Secondary outcomes (2)
Overall survival (OS)
from the date of diagnosis to death or last follow up
Measured: up to 72 months
Surgical Morbidity
including postoperative pancreatic fistula (B/C), bile leakage (B/C), delayed gastric emptying (B/C), postpancreatectomy haemorrhage (B/C), postoperative chyle leak (B/C), postoperative intra-abdominal infection.
Measured: 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatoduodenectomyStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Chongyi Jiang, PhD, Principal investigator, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703581
- Sponsor's protocol ID
- Huadong Hospital to Fudan
- Status last verified
- Jul 2023
- First submitted
- 19 Jan 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT05703581
- Acronym / sponsor ID
- Huadong Hospital to Fudan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 30 Jan 2023 (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.
Aim of the study :
To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .
Methods :
Patients who underwent pancreatoduodenectomy or Distal Pancreatectomy between 01 September 2016 and 30 December 2022 will be included in this retrospective analysis. 3D reconstruction is performed with preoperative enhanced CT, then the region of "Heidelberg Triangle" is categorized . The operation is completed by the same operation team. According to the operation mode, patients were divided into TRIANGLE group and non-TRIANGLE group and And followed up until recurrence, death or missed.
Detailed description
The "Heidelberg Triangle" is an anatomical area composed of Common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV).
This area is considered to be the common site of recurrence after pancreatic surgery.
Recent studies have shown that TRIANGLE operation can improve the state of the cutting edge and has potential value in improving the prognosis. However, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after TRIANGLE operation are insufficient.
The aim of the present study is to evaluate the effect and safety of "Heidelberg Triangle" dissection combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD(TRIANGLE) | – | Procedure: TRIANGLE operationPatients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy |
| PD(non-TRIANGLE) | – | –Patients with pancreatic head cancer or periampullary cancer underwent pancreatoduodenectomy with standard lymphadenectomy |
| DP(TRIANGLE) | – | Procedure: TRIANGLE operationPatients with carcinoma of the body and tail of the pancreas underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with distal pancreatectomy and standard lymphadenectomy |
| DP(non-TRIANGLE) | – | –Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent undergo pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation
Key inclusion criteria (3 listed)
- Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation.
- Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery.
- Be able to comply with the research visit plan and other program requirements
Key exclusion criteria (4 listed)
- Patients accompanied by other systemic malignancies.
- Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery.
- Pregnant and lactating women.
- Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.
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 |
|---|---|---|
| TRIANGLE operationdissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV) | Procedure or surgery | DP(TRIANGLE), PD(TRIANGLE) |
Primary outcome
Recurrence free survival (RFS)
Time frame: up to 72 months
from the date of surgery to the first radiographic or pathologic evidence of recurrence.
2 secondary outcomes
Overall survival (OS)
Time frame: up to 72 months
Surgical Morbidity
Time frame: 90 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Chongyi Jiang, PhD principal investigator
Huadong 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 Pancreatoduodenectomy and Periampullary Carcinoma, run by Fudan 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 3 inclusion and 4 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 1 Aug 2023. 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 Chongyi Jiang, PhD (+86-18101802916, jiangzhongyi9@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (RFS) (time frame: up to 72 months). 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 1 Aug 2023.