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

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725590
• Other study ID #: 2022-0976
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: August 2026

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Sheng Yan, Doctor
• Phone: 13957161680
• Email: shengyan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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; ? 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; ? 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; ? Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Huizhou Municipal Central Hospital, Linping First People's Hospital, Ningbo No. 1 Hospital, Ruian People's Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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