Pancreatic fistula
Conditions
Interventions
Experimental group:Postoperative administration of drotaverine: 40 mg intravenously twice daily from postoperative day (POD) 0 to 6, followed by 40 mg orally three times daily from POD 7 to 12, contin
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years (as of the date of signing the informed consent form). 2. Planned to undergo distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS) via laparotomy or minimally invasive (laparoscopic/robotic) approach. 3. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1, or American Society of Anesthesiologists (ASA) physical status classification I–III, ensuring that the patient can tolerate major surgery. 4. Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Use of anti-gastrointestinal smooth muscle spasm drugs within 1 month before surgery 2. Patients with distant metastasis (including peritoneal metastasis, liver metastasis, distant lymph node metastasis) and surrounding organ invasion require simultaneous surgical resection 3. Combined with other tumors should be resected at the same time 4. Previous digestive tract reconstruction or pancreatic surgery 5. Prior oddi sphincterotomy or pancreatic duct stenting 6. Acute pancreatitis occurred within 2 weeks before the study intervention 7. Vital organ dysfunction: a. Renal insufficiency: estimated glomerular filtration rate (eGFR) 1.5 times the upper limit of normal (ULN), or need for long-term renal replacement therapy; b. Cardiac insufficiency: New York Heart Association (NYHA) functional class >= III, or left ventricular ejection fraction (LVEF) 3 times the upper limit of normal (except obstructive jaundice). d. Pulmonary insufficiency: Forced expiratory volume in 1 second (FEV1) =3) at rest. 8. Presence of uncontrolled intra-abdominal infection, biliary tract infection (cholangitis), or systemic infection before surgery. 9. Allergic to the active ingredient of drotavirine or any other ingredient (such as soy lecithin) or sodium polymetabisulfite 10. Pregnancy or lactation 11. Is participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drain fluid amylase (DFA); | — |
Countries
China
Contacts
Public ContactHaoming Lin
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed