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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05703581
Other study ID # Huadong Hospital to Fudan
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date February 1, 2024

Study information

Verified date July 2023
Source Fudan University
Contact Chongyi Jiang, PhD
Phone +86-18101802916
Email jiangzhongyi9@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 . 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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Intervention

Procedure:
TRIANGLE operation
dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)

Locations

Country Name City State
China Huadong Hospital affiliated to Fudan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence free survival (RFS) from the date of surgery to the first radiographic or pathologic evidence of recurrence. up to 72 months
Secondary Overall survival (OS) from the date of diagnosis to death or last follow up up to 72 months
Secondary 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. 90 postoperative days
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