Post-pancreatectomy acute pancreatitis
Conditions
Interventions
Indomethacin Group:100 mg indomethacin suppository will be administered within 5 minutes after anesthesia. On postoperative day 1 (POD1), a 50 mg indomethacin suppository will be given twice, once in
Placebo Group:Placebo suppositories will be administered three times at the same time points as the indomethacin group: within 5 minutes after anesthesia, and in the morning and afternoon of postopera
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Age between 18 and 75 years; 2 Scheduled to undergo pancreaticoduodenectomy; 3 Truly informed and willing to participate in this study, with written informed consent signed.
Exclusion criteria
Exclusion criteria: 1 Allergy to indomethacin suppositories, aspirin, or other NSAIDs; 2 Use of NSAIDs within the past 7 days (aspirin =300 mg is acceptable); 3 Rectal disease or inability to tolerate rectal suppositories; 4 Severe cardiopulmonary complications; 5 Renal insufficiency (serum creatinine >1.4 mg/dL); 6 Concurrent known malignant tumors or other abdominal neoplastic diseases; 7 History of upper abdominal surgery; 8 Elevated serum amylase/lipase levels above the upper normal limit within one week before surgery; 9 Preoperative CT scan indicating acute pancreatic inflammation; 10 Known chronic calcific pancreatitis; 11 Scheduled for surgical procedures other than pancreaticoduodenectomy, including total pancreatectomy, distal pancreatectomy, central pancreatectomy, or tumor enucleation; 12 Refusal or inability to cooperate with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-pancreaticoduodenectomy acute pancreatitis (ISGPS classification); | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of postoperative hyperamylasemia (ISGPS classification);The incidence of major complications (Clavien-Dindo >= 3);The incidence of postoperative pancreatic fistula (ISGPS classification);The incidence of post-pancreatectomy hemorrhage (ISGPS classification);The incidence of delayed gastric emptying (ISGPS classification);The incidence of postoperative infection;Relaparotomy;Mortality;Postoperative length of stay;Total hospitalization cost;Postoperative C-reactive protein (CRP) level; | — |
Countries
China
Contacts
Public ContactQiang Xu
Peking Union Medical College Hospital
Outcome results
None listed