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

NCT05725590 | Recruiting

• 1 other identifier: 2022-0976
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

Clinically relevant postoperative pancreatic fistula; External pancreatic duct stent; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of other complications

  1 month after the surgery completion

Study Arms (2)

external pancreatic duct stent

EXPERIMENTAL

Procedure: External pancreatic duct stent

internal pancreatic duct stent

EXPERIMENTAL

Procedure: Internal pancreatic duct stent

Interventions

External pancreatic duct stent PROCEDURE

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.

external pancreatic duct stent

Internal pancreatic duct stent PROCEDURE

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.

internal pancreatic duct stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Ningbo No. 1 Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• Linping First People's Hospital: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheng Yan, Doctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

• Yuancong Jiang, Doctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Yan, Doctor

CONTACT

13957161680; shengyan@zju.edu.cn

Guogang Li, Doctor

CONTACT

13819198620; liguogangnag@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 2, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CN (1)