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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Procedure: External pancreatic duct stent; Procedure: Internal pancreatic duct stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheng Yan, Doctor; Phone Number: 13957161680; Email: shengyan@zju.edu.cn
• Study Contact Backup: Name: Guogang Li, Doctor; Phone Number: 13819198620; Email: liguogangnag@163.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    • Contact: Yuancong Jiang, Doctor; Phone Number: 18868107327; Email: jiangyuancong@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: external pancreatic duct stent	Procedure: External pancreatic duct stent; 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.
EXPERIMENTAL: internal pancreatic duct stent	Procedure: Internal pancreatic duct stent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after the surgery completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after the surgery completion

Collaborators and Investigators

• 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
• Investigators: Study Chair: Sheng Yan, Doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; Principal Investigator: Yuancong Jiang, Doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2023
• Primary Completion (ANTICIPATED): February 1, 2026
• Study Completion (ANTICIPATED): August 1, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 13, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pancreaticoduodenectomy; Clinically relevant postoperative pancreatic fistula; External pancreatic duct stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: 2022-0976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be made available from the author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No