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A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy

Primary Purpose

Pancreatic Fistula

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
External pancreatic duct stent
Internal pancreatic duct stent
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Fistula focused on measuring Clinically relevant postoperative pancreatic fistula, External pancreatic duct stent, Pancreaticoduodenectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed; The patient has no combined organic diseases in the heart, lungs, or kidneys; No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study. Exclusion Criteria: Previous history of other tumors or upper abdominal surgery; ② Multiple lesions and distant metastasis; Patients with organic diseases of important organs such as the heart, lung, and kidney, who cannot tolerate surgery, or patients who are more than 75 years old or less than 18 years old; ④ Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

external pancreatic duct stent

internal pancreatic duct stent

Arm Description

Outcomes

Primary Outcome Measures

The incidence of CR-POPF
The primary endpoint of this retrospective study was the incidence of CR-POPF, which was graded according to the definition set forth by ISGPS in 2016.

Secondary Outcome Measures

The incidence of other complications
The secondary endpoints of this retrospective study included the incidence of delayed gastric emptying (DGE), postoperative pancreatic hemorrhage (PPH), bile leakage, infection and mortality, which were graded according to the Clavien-Dindo Classification.

Full Information

First Posted
February 2, 2023
Last Updated
February 2, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo No. 1 Hospital, Huizhou Municipal Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ruian People's Hospital, Linping First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05725590
Brief Title
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Official Title
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Ningbo No. 1 Hospital, Huizhou Municipal Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ruian People's Hospital, Linping First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.
Detailed Description
Pancreatic cancer, with its associated poor prognosis, is one of the most insidious and lethal cancers globally. Indeed, pancreatic cancer has been listed as the fourth leading cause of cancer-related deaths in developed countries, and it may replace colorectal cancer as the second-leading cause of cancer-related deaths by 2030. Pancreaticoduodenectomy is the standard treatment for periampullary carcinoma, especially pancreatic head tumors. However, the incidence of postoperative complications, especially postoperative pancreatic fistula, remains as high as 25%-50%, which limits the dissemination of pancreaticoduodenectomy. An external pancreatic duct stent is one of the methods used to prevent pancreatic fistula. A large number of studies, including prospective randomized trials as well as meta-analyses, have shown that external pancreatic duct stents significantly decrease the rate of pancreatic fistula and shorten the length of hospital stay. Paradoxically, several studies have shown that external pancreatic duct stents have no effect and may even increase the incidence of postoperative pancreatic fistula. In a meta-analysis, Dong et al. observed that the use of an external pancreatic duct stent was associated with a significantly lower incidence of pancreatic fistula in patients at high risk for pancreatic fistula compared with an internal stent, but there was no definitive conclusion because of the low quality of the evidence. In 2019, Mungroop et al. proposed the Updated Alternative Fistula Risk Score (ua-FRS) according to the International Study Group of Pancreatic Surgery (ISGPS), which quantitatively validated the risk of pancreatic fistula and assessed the benefits of pancreatic duct stents in patients at different levels of risk. Moreover, ISGPS redefined the classification criteria for pancreatic fistula (Grade A) as a biochemical leak, which had no significant clinical impact on the clinical prognosis. In addition, the position statement by ISGPS indicated that, due to the lack of high-quality evidence, the pancreatic duct stent was not routinely recommended during pancreaticoenteric anastomosis, but external stenting can be considered in high-risk glands. Therefore, it is necessary to systematically re-investigate the safety and effectiveness of external pancreatic duct stents for the prevention and treatment of clinically relevant postoperative pancreatic fistula (CR-POPF) in both high-risk and low-risk patients. This retrospective study was conducted to evaluate the differences between external and internal pancreatic stents using the ua-FRS scoring system, based on the hypothesis that the use of an external stent in high-risk patients could decrease the rates of CR-POPF compared with an internal stent after pancreaticoduodenectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula
Keywords
Clinically relevant postoperative pancreatic fistula, External pancreatic duct stent, Pancreaticoduodenectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
external pancreatic duct stent
Arm Type
Experimental
Arm Title
internal pancreatic duct stent
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
External pancreatic duct stent
Intervention Description
All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The external pancreatic duct stent left the other end exteriorized through the proximal jejunum via a small enterotomy that was fixed in the abdominal wall.
Intervention Type
Procedure
Intervention Name(s)
Internal pancreatic duct stent
Intervention Description
All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The internal pancreatic duct stent, a silicone catheter with multiple side pores, was inserted into the main pancreatic duct and the other end was placed in the jejunum cavity.
Primary Outcome Measure Information:
Title
The incidence of CR-POPF
Description
The primary endpoint of this retrospective study was the incidence of CR-POPF, which was graded according to the definition set forth by ISGPS in 2016.
Time Frame
1 month after the surgery completion
Secondary Outcome Measure Information:
Title
The incidence of other complications
Description
The secondary endpoints of this retrospective study included the incidence of delayed gastric emptying (DGE), postoperative pancreatic hemorrhage (PPH), bile leakage, infection and mortality, which were graded according to the Clavien-Dindo Classification.
Time Frame
1 month after the surgery completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed; The patient has no combined organic diseases in the heart, lungs, or kidneys; No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study. Exclusion Criteria: Previous history of other tumors or upper abdominal surgery; ② Multiple lesions and distant metastasis; Patients with organic diseases of important organs such as the heart, lung, and kidney, who cannot tolerate surgery, or patients who are more than 75 years old or less than 18 years old; ④ Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Yan, Doctor
Phone
13957161680
Email
shengyan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guogang Li, Doctor
Phone
13819198620
Email
liguogangnag@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng Yan, Doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuancong Jiang, Doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuancong Jiang, Doctor
Phone
18868107327
Email
jiangyuancong@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be made available from the author on reasonable request.

Learn more about this trial

A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy

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