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Trial Title:
Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
NCT ID:
NCT05703581
Condition:
Pancreatoduodenectomy
Periampullary Carcinoma
Pancreatic Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
TRIANGLE operation
Description:
dissection the region composed of common hepatic artery (CHA), superior mesenteric artery
(SMA) and superior mesenteric vein (SMV)
Arm group label:
DP(TRIANGLE)
Arm group label:
PD(TRIANGLE)
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 .
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 .
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huadong Hospital affiliated to Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chongyi Jiang, M.D.
Email:
jiangzhongyi9@sina.com
Investigator:
Last name:
Jiahao Chen, M.S.
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
February 1, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703581
