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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • External pancreatic duct stent

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: external pancreatic duct stentExperimental treatment 1 intervention
Group B: internal pancreatic duct stentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 month after the surgery completion

Secondary outcomes

1

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.

Time frame
1 month after the surgery completion

Other outcomes

Sponsors and contacts

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

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