Preoperative/Neoadjuvant Therapy and Vascular Debranching Followed by Resection for Locally Advanced Pancreatic Cancer

Not Applicable

Terminated

• Conditions: Pancreas Cancer
• Interventions: Procedure: Visceral Debranching

• Registration Number: NCT04136769
• Lead Sponsor: Ulrich Ronellenfitsch, MD

Brief Summary

Pancreatic cancer continues to have a poor prognosis. Many patients are diagnosed with advanced disease. In a considerable proportion of these patients, the tumor has contact with or invades into arterial blood vessels supplying the liver or bowel. Moreover, some patients have anatomical variations or Stenosis of these vessels. All such cases require a surgical reconstruction of the blood vessels upon pancreatic cancer resection in order to prevent that the liver or bowel are not sufficiently supplied with blood anymore. Performing such arterial reconstruction in one operation along with tumor resection is associated with a relevant risk of complications or even death.

This trial evaluates if the approach of 'visceral debranching', i.e. surgical reconstruction of arterial blood vessels supplying the liver or bowel, prior to chemotherapy and finally tumor resection in patients with locally advanced pancreatic cancer, is feasible.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2020-02-07
• Status Verified: 2024-12
• Primary Completion: 2024-12-04
• Study Completion: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Visceral Debranching	After trial enrolment, patients undergo visceral debranching. After visceral debranching, patients proceed to neoadjuvant chemotherapy. The therapy as such is not a formal part of the trial protocol. The specific chemotherapy regimen and its duration are decided individually by treating physicians. Tumor resection should be performed two to four weeks after completion of chemotherapy. Prior to resection, re-staging and verification of vascular reconstruction patency are carried out. The specific procedure for tumor resection and intestinal tract reconstruction is at the choice of the treating surgeon. It should follow oncological principles and aim at complete removal of the tumor and regional lymph nodes. Usually, resection will be done as pancreatoduodenectomy with or without distal gastrectomy (Whipple's procedure or pylorus-preserving Whipple's procedure), distal pancreatectomy with splenectomy, or total pancreatectomy with splenectomy.

Primary Outcome Measures

Name	Time	Method
Feasibility of visceral debranching	Six weeks	Proportion of patients proceeding to neoadjuvant chemotherapy (at least one dose administered within six weeks from the debranching procedure) among all patients undergoing visceral debranching

Secondary Outcome Measures

Name	Time	Method
Completeness of resection	Three months	Proportion of patients with clear resection margins (R0) upon pancreatic cancer resection following visceral debranching and neoadjuvant chemotherapy among all patients undergoing visceral debranching
Perioperative morbidity (visceral debranching)	Four weeks	Perioperative in-hospital morbidity associated with the visceral debranching procedure, measured according to the Clavien-Dindo-Classification of surgical complications
Recurrence-free survival	Three years	Time between resection and the appearance of local recurrence, peritoneal carcinomatosis, or distant metastases. For patients who are not resected, recurrence-free survival will be defined as zero
Overall survival	Three years	Time between time between first diagnosis, which is assumed to be equivalent to study enrolment, and death, independent of the cause of death
Completion of therapy	Three months	Proportion of patients proceeding to attempted tumor resection among all patients undergoing visceral debranching
Perioperative morbidity (pancreatic cancer resection)	Four weeks	Perioperative in-hospital morbidity associated with pancreatic cancer resection, measured according to the Clavien-Dindo-Classification of surgical complications
Toxicity of chemotherapy	Three months	Toxicity during neoadjuvant chemotherapy, measured according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Progression-free survival	Three years	Time between time between first diagnosis, which is assumed to be equivalent to study enrolment, and documented progression. For patients who are not resected, progression-free survival will be defined as zero

Trial Locations

Locations (2)

University Hospital, Dpt. of Visceral, Vascular and Endocrine Surgery; 🇩🇪 Halle (Saale), Germany

University Hospital; 🇩🇪 Ulm, Germany