Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction

November 5, 2024 updated by: Xian-Jun Yu, Fudan University

Long-term Outcome in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Exposure, Repair or Reconstruction: A Prospective Cohort Study

The aim of this study is to evaluate the impact of concomitant main pancreatic duct exposure, repair, or reconstruction during minimally invasive pancreatic tumor enucleation on long-term patient prognosis and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Standard surgical procedures for benign or low-grade malignant pancreatic tumors is associated with increased risks of postoperative complications and long-term pancreatic functional impairment, while parenchyma-sparing pancreatectomy such as enucleation can reduce the incidence of complications and preserve healthy parenchyma, thereby preserve both endocrine and exocrine pancreatic function. It has been reported that pancreatic tumor enucleation is a safe and feasible approach in preserving normal physiological function in patients undergoing pancreatic surgery.

With the growing emphasis on routine screenings and the application of high-quality thin-slice imaging techniques, the detection rates of pancreatic tumors have witnessed a steady increase. Additionally, there is a notable trend towards younger patients being diagnosed with pancreatic tumors. Consequently, in conjunction with ensuring safe and thorough tumor resection while maximizing preservation of pancreatic function, there is a current clinical demand to further reduce surgical trauma.

Literature reviews and meta-analyses have demonstrated that minimally invasive enucleation procedures offer well-known advantages associated with minimally invasive approaches, such as shorter postoperative hospital stays and lower overall complication rates. While the occurrence rate of severe complications, such as postoperative hemorrhage, remains relatively low, the development of postoperative pancreatic fistula (POPF) continues to pose a challenging issue.

The distance between the tumor and the main pancreatic duct (MPD) is considered a crucial factor influencing the occurrence of POPF after enucleation. However, these data have been rarely described in previous studies, making it challenging to accurately assess their actual impact on the rate of POPF occurrence. Heeger et al. suggested that the risk of POPF increases with closer proximity of the tumor to the MPD. The incidence of POPF was higher in deep-seated tumors after pancreatic enucleation (distance to MPD <3 mm) compared to superficial tumors (>3 mm) (73.3% vs. 30.0%, P=0.002). Other studies have even limited this critical distance to 2mm. Some research has indicated that if the tumor invades or encases the MPD, enucleation surgery should be contraindicated, and standard resection should be preferred to avoid the risk of POPF postoperatively. However, a retrospective analysis by Strobel et al. on 166 cases of pancreatic tumor enucleation demonstrated that even tumors in close proximity to the MPD can be safely resected, although their study did not include cases with tumor encasement of the MPD.

During the expansive growth of solid tumors such as neuroendocrine tumors and solid pseudopapillary neoplasms, they can compress the MPD, causing inflammatory adhesions. Cystic tumors can also surround the MPD as they grow. Enucleation of these tumors may inevitably lead to exposure, injury, or transection of the MPD, necessitating repair and reconstruction. Recent years have seen successful cases reported of end-to-end anastomosis of the MPD. Minimally invasive techniques have also facilitated the promotion of MPD repair or bridging reconstruction surgeries. However, there remains a lack of comprehensive research data in this field.

The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD exposure, repair, or reconstruction, the control of POPF, and the long-term prognosis and quality of life of patients after MPD repair or reconstruction remain unclear. Therefore, this study aims to conduct a prospective cohort study. The results of this study will serve as a valuable reference for clinical practice and promote the development and application of minimally invasive pancreatic tumor enucleation procedures.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 18 and 75 years, regardless of gender;
  2. patients with solitary benign or low-grade malignant pancreatic tumors, including NET, SPN, and cystic tumors;
  3. eligible for pancreatic parenchyma-sparing resection (PSR) according to contemporary guidelines;
  4. patients with an ECOG performance status of 0 or 1;
  5. successfully received MIEN (laparoscopic or robotic)

Exclusion Criteria:

  1. body mass index > 35 kg/m2;
  2. concomitant malignancies;
  3. intraoperative frozen section or postoperative pathology indicating malignancy, requiring conversion to oncologic resection;
  4. loss to follow-up within 90 days postoperatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPD Manipulation
During laparoscopic or robotic pancreatic tumor enucleation, tumors located near or surrounding the main pancreatic duct (MPD) can result in the exposure, injury, or transection of the MPD, requiring MPD repair and reconstruction.
Procedure: MPD Exposure, Repair or Reconstruction
During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is injured due to its proximity or encasement by the tumor, MPD manipulation is performed. MPD manipulation is categorized into three scenarios: exposed but not injured; simple suture repair (using 5-0/6-0 PROLENE polypropylene suture); and suture repair/reconstruction following stent insertion. Using the F6 ventricular drainage catheter with 1-2 side holes trimmed as the stent, typically requiring 10 cm for passage through the duodenal papilla and 3-4 cm if not passing through. Following stent placement, intermittent suturing reconstructs the MPD, with one stitch securing the stent by passing through both the stent side wall and the MPD.
No Intervention: MPD not exposed
In laparoscopic or robotic pancreatic tumor enucleation procedures where the MPD remains unexposed, there is no need for MPD repair and reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
Time Frame: Within 90 days after surgery.
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
Within 90 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: From the date of surgery to 1 month after surgery.
R0 margin rate on postoperative pathological assessment.
From the date of surgery to 1 month after surgery.
Recurrence-free survival (RFS)
Time Frame: Through study completion, an average of 3 year.
The time of surgery to the time of tumor recurrence or death.
Through study completion, an average of 3 year.
Perioperative complication rate according to the Clavien-Dindo classification
Time Frame: Within 90 days after surgery.
Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate
Time Frame: Within 90 days after surgery.
Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
Within 90 days after surgery.
Delayed gastric emptying (DGE) rate
Time Frame: Within 90 days after surgery.
Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
Within 90 days after surgery.
Reoperation rate
Time Frame: Within 90 days after surgery.
Reoperation rate within 90 days after surgery.
Within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption
Time Frame: Through study completion, an average of 3 year.
Postoperative pancreatic enzyme-dependent malabsorption rate.
Through study completion, an average of 3 year.
Rate of new-onset diabetes
Time Frame: Through study completion, an average of 3 year.
Postoperative new-onset diabetes rate.
Through study completion, an average of 3 year.
Life quality satisfaction evaluated according to EORTC C30 scale
Time Frame: Through study completion, an average of 3 year.
The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
Through study completion, an average of 3 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Chinese PLA General Hospital
Tongji Hospital
Qilu Hospital of Shandong University
The Affiliated Hospital of Xuzhou Medical University
The Third Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Xianjun Yu, MD, PhD, Fudan University
  • Study Director: Xiaowu Xu, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-MIEN-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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