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Comparison of the impact of continuous pressure-balanced irrigation and synchronous drainage versus simple drainage on the incidence of clinically relevant pancreatic fistula after pancreaticoduodenectomy: a multicenter, prospective, randomized controlled study

Comparison of the impact of continuous pressure-balanced irrigation and synchronous drainage versus simple drainage on the incidence of clinically relevant pancreatic fistula after pancreaticoduodenectomy: a multicenter, prospective, randomized controlled study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124170
Enrollment
Unknown
Registered
2026-05-08
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Pancreatic tumor

Interventions

Flush and Drainage Group:Postoperatively, a double-lumen irrigation drainage tube (Yilei? disposable irrigation drainage tube) is placed behind the pancreaticojejunostomy anastomosis. One lumen is use
Control group:Postoperatively, a conventional drainage tube (ordinary plasma drainage tube) is placed behind the pancreaticojejunostomy anastomosis and connected to a constant negative pressure (-80 t

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old; 2. Planned open pancreaticoduodenectomy (regardless of the pancreatic-enteric anastomosis method); 3. Preoperative diagnosis of a mass in the pancreatic head or periampullary region, whether benign or malignant; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Liver combined with major organ resection (such as liver resection, colon resection, etc.); 3. Presence of active intra-abdominal infection or sepsis before surgery; 4. Severe coagulation dysfunction; 5. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Postoperative clinically relevant pancreatic fistula.;Postoperative gastrointestinal function recovery time;Postoperative drainage tube indwelling time;Postoperative hospital stay;30-day readmission rate after surgery;Reoperation rate within 30 days post-surgery;30-day postoperative mortality;

Secondary

MeasureTime frame
Postoperative complication status;Postoperative liver function status;Postoperative electrolyte status;

Countries

China

Contacts

Public ContactLi Ang

West China Hospital of Sichuan University

angli@scu.edu.cn+86 189 8060 6692

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026