Evaluating the Heidelberg Triangle dissection in pancreatic surgeries
Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
Fudan University · NCT05703581
This study is testing a new surgical technique called the 'Heidelberg Triangle' to see if it helps people with pancreatic cancer live longer and have fewer recurrences after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05703581 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of the 'Heidelberg Triangle' dissection technique when combined with pancreatoduodenectomy or distal pancreatectomy for patients with pancreatic cancer and periampullary carcinoma. It involves a retrospective analysis of patients who underwent these surgeries between September 2016 and December 2022, categorizing them into TRIANGLE and non-TRIANGLE groups based on the surgical approach used. The study will utilize 3D reconstruction from preoperative enhanced CT scans to analyze the impact of this dissection method on recurrence and survival rates.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with resectable or borderline resectable pancreatic malignant tumors or periampullary carcinoma who can tolerate surgery.
Not a fit: Patients with other systemic malignancies or serious uncontrolled diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and prognosis for patients with pancreatic cancer.
How similar studies have performed: While recent studies suggest potential benefits of the TRIANGLE operation, data on its effectiveness remains limited, indicating this approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery. 3. Be able to comply with the research visit plan and other program requirements Exclusion Criteria: 1. Patients accompanied by other systemic malignancies. 2. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery. 3. Pregnant and lactating women. 4. 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.
Where this trial is running
Shanghai
- Huadong Hospital affiliated to Fudan University — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Chongyi Jiang, PhD — Huadong Hospital
- Study coordinator: Chongyi Jiang, PhD
- Email: jiangzhongyi9@126.com
- Phone: +86-18101802916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatoduodenectomy, Periampullary Carcinoma, Pancreatic Cancer