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Impact of external application of mirabilite on clinical and economic in pancreatic surgery: A prospective, open label, randomized controlled clinical trial

Impact of external application of mirabilite on clinical and economic in pancreatic surgery: A prospective, open label, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077500
Enrollment
Unknown
Registered
2023-11-10
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

pancreatic tumour

Interventions

mirabilite group:external application of mirabilite
control group:No

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Between the ages of 19 and 80 years, regardless of gender; ? Feasible standard pancreatic body tail resection or pancreaticoduodenectomy; ? Physical fitness score ECOG 0~2; ? Imaging examination reveals pancreatic body tail occupation, pancreatic head occupation, jugular abdominal occupation, and in case of malignant tumors, distant metastasis and ascites should not be detected; ? No obvious invasion of abdominal trunk and superior mesenteric artery; ? No obvious invasion of the abdominal trunk and superior mesenteric artery; ? No obvious contraindication to surgery; ? Expected postoperative survival = 3 months; ? Ability to comply with the study visit plan and other protocol requirements; ? Participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? Localized unresectable pancreatic body tail adenocarcinoma (refer to the 2021 edition of the NCCN Pancreatic Cancer Guidelines); ? Requires combined organ/vascular resection (e.g., stomach, colon, celiac trunk, etc.); ? Total pancreatectomy is required; ? Those with distant metastasis or ascites detected by imaging; ? Those with severe impairment of cardiac, hepatic and renal functions (cardiac function grade 3 to 4, ALT and/or AST exceeding the upper limit of normal by more than 3 times, Cr exceeding the upper limit of normal); ? Combination of other malignant tumors or hematological diseases; ? Pregnant, planning to be pregnant and breastfeeding women (early pregnancy is diagnosed when urinary HCG>2500IU/L); ? Tumor resection prior to any manner of anti-tumor treatment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy; ? Clinical subjects who have participated in other pancreatic cancer treatments within three months

Design outcomes

Primary

MeasureTime frame
Incidence of grade B and C pancreatic fistulae;Puncture drainage rate of abdominal fluid collection;

Secondary

MeasureTime frame
cost of hospitalization; Indicators of immune-related inflammation;visual analogue scale;

Countries

China

Contacts

Public Contactshisi

Fudan University Shanghai Cancer Center

shisi@fudanpci.org+86 159 0098 3606

Outcome results

None listed

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