Clinical trial · Interventional
Dachengqi Decoction for Enhancing Early Gastrointestinal Recovery After Whipple Surgery
Clinical Study on the Effect of Traditional Chinese Medicine Formula Dachengqi Decoction on Early Gastrointestinal Function Recovery After Whipple Surgery
NCT06948474CI-TRIAL-00089001active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 impact on postoperative nutritional status, hospitalization duration, and complication rates, thereby providing evidence for optimizing postoperative rehabilitation strategies in pancreaticoduodenectomy patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Whipple Operation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dachengqi decoction | Drug | — | UNRESOLVED |
| modified gastrointestinal dual-lumen feeding tube | Procedure | — | UNRESOLVED |
| Normal Saline (0.9% NaCl) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dachengqi Decoction Experimental Group
- description
- All study participants underwent intraoperative placement of modified gastrointestinal dual-lumen feeding tubes with distal ends positioned 15-20 cm distal to the gastrojejunostomy anastomosis (all devices were uniformly procured by China-Japan Friendship Hospital). Participants received Dachengqi decoction (50 ml BID) via pump infusion at 10 ml/h starting 12 hours postoperatively, continuing through postoperative days 1-3.
- interventionNames
- Drug: Dachengqi decoction
- Procedure: modified gastrointestinal dual-lumen feeding tube
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- All participants received intraoperative placement of modified gastrointestinal dual-lumen feeding tubes (15-20 cm distal to gastrojejunostomy anastomosis; devices uniformly procured by China-Japan Friendship Hospital). Participants were administered glucose and sodium chloride injection (50 ml BID) via pump infusion at 10 ml/h starting 12 hours postoperatively, continuing through postoperative days 1-3.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.