NCT06948474

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Whipple Operation

Interventions

Type	Name	Description
DRUG	Dachengqi decoction	experimental Participants received Dachengqi decoction (50 ml BID) via pump infusion at 10 ml/h starting 12 hours postoperatively, continuing through postoperative days 1-3.
PROCEDURE	modified gastrointestinal dual-lumen feeding tube	experimental and control group 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).
DRUG	Normal Saline (0.9% NaCl)	control group 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-04-29
• Last updated: 2025-04-29

Locations

1 site across 1 country: China