Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06024343

Collaborator

The Third Affiliated Hospital of Soochow University (Other), Tongji Hospital (Other), Qilu Hospital of Shandong University (Other), Chinese PLA General Hospital (Other), The Affiliated Hospital of Xuzhou Medical University (Other)

112

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Tumor, Benign Pancreatic Neuroendocrine Tumor Solid Pseudopapillary Tumor of the Pancreas	Procedure: MPD Repair or Reconstruction	N/A

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. In 2021, Professor Liu Rong and colleagues introduced the concept of pancreatic duct surgery and outlined four main surgical approaches: MPD repair, pancreatic end-to-end anastomosis, local excision of branch-duct intraductal papillary mucinous neoplasms, and MPD replacement. However, detailed research data in this field are still lacking.

The safety and feasibility of minimally invasive pancreatic tumor enucleation procedures involving MPD 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, multicenter, single-arm clinical trial. 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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Long-term Prognosis and Quality of Life in Minimally Invasive Pancreatic Enucleation With Main Pancreatic Duct Repair or Reconstruction: A Multicenter Prospective Single-Arm Clinical Trial

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MPD Repair or Reconstruction In laparoscopic or robotic pancreatic tumor enucleation, it is inevitable that the main pancreatic duct (MPD) may be damaged due to its proximity or encasement by the tumor. After tumor resection, MPD repair or reconstruction can be performed. If there is no associated MPD dilation, a MPD stent can be inserted and secured with interrupted sutures. When placing the stent, it is important to ensure that the distal end of the stent passes through the duodenal papilla to sufficiently reduce the pressure inside the MPD. Vascular remnants or branch pancreatic duct remnants on the pancreatic resection surface should be sutured. After hemostasis, efforts should be made to restore the serosalization of the pancreatic resection surface. The surface can also be left exposed or covered with ligamentum teres hepatis. Fish-mouth-shaped incisions can be closed, but care should be taken to avoid creating dead spaces that may lead to fluid accumulation and hinder drainage.	Procedure: MPD Repair or Reconstruction During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is damaged due to its proximity or encasement by the tumor, MPD repair or reconstruction is performed.

Arm

Intervention/Treatment

Experimental: MPD Repair or Reconstruction

In laparoscopic or robotic pancreatic tumor enucleation, it is inevitable that the main pancreatic duct (MPD) may be damaged due to its proximity or encasement by the tumor. After tumor resection, MPD repair or reconstruction can be performed. If there is no associated MPD dilation, a MPD stent can be inserted and secured with interrupted sutures. When placing the stent, it is important to ensure that the distal end of the stent passes through the duodenal papilla to sufficiently reduce the pressure inside the MPD. Vascular remnants or branch pancreatic duct remnants on the pancreatic resection surface should be sutured. After hemostasis, efforts should be made to restore the serosalization of the pancreatic resection surface. The surface can also be left exposed or covered with ligamentum teres hepatis. Fish-mouth-shaped incisions can be closed, but care should be taken to avoid creating dead spaces that may lead to fluid accumulation and hinder drainage.

Procedure: MPD Repair or Reconstruction

During laparoscopic or robotic pancreatic tumor enucleation, if the main pancreatic duct (MPD) is damaged due to its proximity or encasement by the tumor, MPD repair or reconstruction is performed.

Outcome Measures

Primary Outcome Measures

Incidence of Clinically Relevant Postoperative Pancreatic Fistula [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.

Secondary Outcome Measures

Perioperative complication rate according to the Clavien-Dindo classification [Within 90 days after surgery.]
Adverse events that occur during or after the surgery, reported according to the Clavien-Dindo classification.
Postoperative pancreatic hemorrhage (PPH) rate [Within 90 days after surgery.]
Postoperative pancreatic hemorrhage (PPH) rate within 90 days after surgery, reported according to the ISGPS definition.
Delayed gastric emptying (DGE) rate [Within 90 days after surgery.]
Delayed gastric emptying (DGE) rate within 90 days after surgery, reported according to the ISGPS definition.
Reoperation rate [Within 90 days after surgery.]
Reoperation rate within 90 days after surgery.
Rate of pancreatic enzyme-dependent malabsorption [Through study completion, an average of 3 year.]
Postoperative pancreatic enzyme-dependent malabsorption rate.
Rate of new-onset diabetes [Through study completion, an average of 3 year.]
Postoperative new-onset diabetes rate.
Life quality satisfaction evaluated according to EORTC C30 scale [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.
R0 resection rate [From the date of surgery to 1 month after surgery.]
R0 margin rate on postoperative pathological assessment.
Recurrence-free survival (RFS) [Through study completion, an average of 3 year.]
The time of surgery to the time of tumor recurrence or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 70 years, regardless of gender.
Solitary benign or low-grade malignant tumor of the pancreas.
Patients evaluated according to guidelines indicating the need for surgery or strongly requesting surgery.
Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
Intraoperative procedure involving repair or reconstruction of the main pancreatic duct.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
Willingness to comply with the study's follow-up plan and other protocol requirements.
Voluntary participation and signed informed consent.

Exclusion Criteria:

Body mass index (BMI) > 35 kg/m2.
Individuals planning pregnancy, currently pregnant, or breastfeeding.
History of major abdominal surgery.
Concurrent presence of other malignant tumors.
Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring curative resection instead.
Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
Participation in other clinical trials simultaneously.

Withdrawal Criteria:

Significant changes in the participant's condition after enrollment that render the study protocol unsuitable or infeasible.
Occurrence of severe complications that impact the implementation of the study plan.
Identification of technical difficulties after enrollment, making the studied treatment protocol impossible to implement.
Emergent need for treatment due to other diseases confirmed after enrollment.
Deviation from the study protocol in the actual administration of treatment.
Voluntary withdrawal or discontinuation of any examinations, treatments, and monitoring required by the study at any stage, for personal reasons of the participant.