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

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05703581
• Collaborator: (none)
• Enrollment: 200
• Anticipated Duration (Months): 11.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatoduodenectomy; Periampullary Carcinoma; Pancreatic Cancer	Procedure: TRIANGLE operation

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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
PD(TRIANGLE) Patients with pancreatic head cancer or periampullary cancer underwent "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy and standard lymphadenectomy	Procedure: TRIANGLE operation; dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)
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	Procedure: TRIANGLE operation; dissection the region composed of common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV)
DP(non-TRIANGLE) Patients with carcinoma of the body and tail of the pancreas underwent distal pancreatectomy with standard lymphadenectomy

Outcome Measures

Primary Outcome Measures

1. Recurrence free survival (RFS) [up to 72 months]

   from the date of surgery to the first radiographic or pathologic evidence of recurrence.

Secondary Outcome Measures

1. Overall survival (OS) [up to 72 months]

   from the date of diagnosis to death or last follow up

2. Surgical Morbidity [90 postoperative days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fudan University

Investigators

• Principal Investigator: Chongyi Jiang, PhD, Huadong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhijun Bao, Director, Fudan University
• ClinicalTrials.gov Identifier: NCT05703581
• Other Study ID Numbers: Huadong Hospital to Fudan
• First Posted: Jan 30, 2023
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 30, 2023