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The effect of different pancreatic duct stent drainage modes on the early curative effect after pancreaticoduodenectomy, a prospective randomized controlled trial

The effect of different pancreatic duct stent drainage modes on the early curative effect after pancreaticoduodenectomy, a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004830
Enrollment
Unknown
Registered
2014-06-20
Start date
2014-07-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The benign and malignant diseases of pancreas and pars ampullaris

Interventions

external pancreatic duct drainage group:pancreatic duct stent is placed outside the body
proximal internal pancreatic duct drainage group:pancreatic duct stent is placed 7-8cm from the pancreatico-jejunal anastomotic stoma in the intestine
distal internal pancreatic duct drainage group:pancreatic duct stent is placed 50-55cm from the pancreatico-jejunal anastomotic stoma in the intestine

Sponsors

Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The patients who are ready to undergo pancreaticoduodenectomy because of the benign and malignant diseases of pancreas and pars ampullaris aged 18-80 years old.

Exclusion criteria

Exclusion criteria: 1. the patient or family refuses to enroll; 2. emergent pancreaticoduodenectomy; 3. a history of abdominal surgery; 4. a history of serious cardiac,pulmonary and renal dysfunction; 5. severe liver cirrhosis, mental disorder or hemodialysis; 6. the tumors can not be resected after exploratory laparotomy; 7. total pancreaticoduodenectomy; 8. receive preoperative neoadjuvant chemotherapy; 9. the pancreatic duct can not be found during the operation.

Design outcomes

Primary

MeasureTime frame
incidence of postoperative pancreatic fistula;postoperative pancreatic fistula healing time;

Secondary

MeasureTime frame
incidence of postoperative related complications;incidence of global postoperative complications;intraoperative blood loss;surgical duration;duration of postoperative hospitalization;perioperative mortality;reoperation rat;

Contacts

Public ContactSun Bei

Department of Pancreatic and Biliary Surgery, The First Affiliated Hospital of Harbin Medical University

sunbei70@tom.com+86 13603656935

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026