Clinical trial NCT06948474: Dachengqi Decoction for Enhancing Early Gastrointestinal Recovery After Whipple Surgery
Official title: Clinical Study on the Effect of Traditional Chinese Medicine Formula Dachengqi Decoction on Early Gastrointestinal Function Recovery After Whipple Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Whipple Operation
Keywords: Pancreatic Cancer
IPMN, Pancreatic
whipple
Pancreaticoduodenectomy
Periampullary
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 impact on postoperative nutritional status, hospitalization duration, and complication rates, thereby providing evidence for optimizing postoperative rehabilitation strategies in pancreaticoduodenectomy patients.

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 study center. Participants will be divided into three groups: the experimental group (15 patients receiving Dachengqi Decoction), the control group (15 patients receiving glucose-sodium chloride solution), and a retrospective blank control group (15 historical cases). Simple randomization will be applied for group allocation.

Intervention:

Experimental Group: Dachengqi Decoction (composed of Houpu 24g, Zhishi 12g, Dahuang 12g, and Mangxiao 9g) will be prepared by the hospital pharmacy. Administered at 50 mL twice daily via jejunal tube infusion (10 mL/h), starting 12 hours postoperatively for three consecutive days.

Control Group: Glucose-sodium chloride solution (250 mL: glucose 12.5g and sodium chloride 2.25g) will be administered using the same protocol.

Blank Control Group: No additional intervention; data will be retrospectively collected from eligible historical cases.

Key Procedures:

Baseline Assessments: Preoperative evaluations include medical history, physical examinations (e.g., bowel sounds), laboratory tests (blood counts, biochemistry, coagulation, inflammatory markers), imaging (CT/MRI), and validated scales (nutritional status, mental health, gastrointestinal function).

Intraoperative Management: Standardized anesthesia and placement of a dual-lumen feeding tube distal to the gastrojejunal anastomosis.

Postoperative Monitoring: Record time to first defecation, flatus, oral intake, ambulation, vomiting frequency, bowel sounds, pain scores, and complications (e.g., delayed gastric emptying \[DGE\]). Imaging (abdominal CT) and laboratory tests will be performed on postoperative days 1, 3, 5, 7, and 30.

Follow-Up: Assessments at 30 days post-surgery will include gastrointestinal function, nutritional status, and adverse events.

Endpoints:

Primary Endpoints: Gastrointestinal function (evaluated via standardized scales) and nutritional status (PG-SGA score) at 1 month postoperatively.

Secondary Endpoints: Total hospitalization duration, time to gastrointestinal recovery (flatus, defecation, oral intake), and incidence of complications (e.g., DGE graded by ISGPS criteria).

Statistical Analysis: Continuous variables will be analyzed using ANOVA or non-parametric tests, while categorical variables will be assessed with chi-square or Fisher's exact tests. Linear/logistic regression and Cox models will be applied for outcome analysis. A sample size of 15 per group was calculated (power=0.9, α=0.05).

Ethics and Compliance: The study protocol and informed consent forms will be approved by the institutional ethics committee. Participants or their legal representatives must provide written consent. Confidentiality of patient data will be maintained, and results will be disseminated through peer-reviewed publications.

Timeline: Patient enrollment is scheduled for completion by March 1, 2026, with final results expected by June 1, 2026.

Eligibility criteria: 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.

Primary outcomes:
measure: One month postoperative evaluation of gastrointestinal function
timeFrame: 1 month after surgery
Secondary outcomes:
measure: postoperative assessment of gastrointestinal functional recovery
timeFrame: From surgery date through postoperative day 30.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: