Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Pancreatic Cancer Clinical Trial

Official title:

Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703581
• Other study ID #: Huadong Hospital to Fudan
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatoduodenectomy
• Periampullary Carcinoma

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