Status:
ACTIVE_NOT_RECRUITING
Dachengqi Decoction for Enhancing Early Gastrointestinal Recovery After Whipple Surgery
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Whipple Operation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To investigate the clinical efficacy of the traditional Chinese medicine formula Dachengqi Decoction in promoting early gastrointestinal function recovery after Whipple surgery, and to evaluate its im...
Detailed Description
Study Design: This prospective, open-label, randomized controlled trial will enroll 45 patients undergoing pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) at the stud...
Eligibility Criteria
Inclusion
- Patients aged 18-75 years, regardless of gender (n=45);
- Meeting American Society of Anesthesiologists (ASA) physical status classification I-II criteria, scheduled to undergo pancreaticoduodenectomy or pylorus-preserving pancreaticoduodenectomy under combined intravenous-inhalational general anesthesia;
- No participation in other clinical trials within 6 months prior to the study initiation;
- Absence of severe preexisting cardiac, neurological, renal, endocrine, or hematologic diseases that may affect surgical outcomes or postoperative prognosis (e.g., unstable angina, heart failure, uncontrolled hypertension, severe neuropathy, psychiatric disorders, renal insufficiency, diabetes, hematologic disorders, severe alcoholic liver disease, substance abuse, or alcoholism);
- Participants free of cognitive impairment, aphasia, or psychiatric disorders, possessing intact communication skills and capable of comprehending and signing the informed consent form.
Exclusion
- Patients aged \<18 or \>75 years;
- Not meeting American Society of Anesthesiologists (ASA) physical status classification I-II criteria;
- History of severe cardiac, neurological, renal, endocrine, or hematopoietic comorbidities that may impact surgical outcomes or postoperative prognosis (e.g., unstable angina, heart failure, uncontrolled hypertension, severe neuropathy, psychiatric disorders, renal insufficiency, diabetes, hematologic diseases, severe alcoholic liver disease, substance abuse, or alcoholism);
- Participants in either treatment group refusing to sign informed consent forms;
- Participation in other clinical trials within 6 months prior to study initiation;
- Patients deemed by investigators unsuitable for efficacy evaluation or unlikely to complete treatment course and follow-up.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06948474
Start Date
August 1 2024
End Date
June 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029