An interventional study of Dachengqi decoction and modified gastrointestinal dual-lumen feeding tube in Whipple Operation, sponsored by China-Japan Friendship Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment
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.
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.
China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Dachengqi decoction · Procedure: modified gastrointestinal dual-lumen feeding tube
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.
Procedure: modified gastrointestinal dual-lumen feeding tube · Drug: Normal Saline (0.9% NaCl)
No specific therapeutic intervention was indicated
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.
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).
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.
One month postoperative evaluation of gastrointestinal function
assessed through three independent systems: Functional bowel recovery: Evaluated through I-FEED scoring system (0-10; lower score reflects better postoperative recovery)
Time frame: 1 month after surgery
postoperative assessment of gastrointestinal functional recovery
Time to first flatus (hours) Time to first bowel movement (hours) Time to oral intake initiation (hours) Time to first ambulation (hours)
Time frame: From surgery date through postoperative day 30.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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China-Japan Friendship Hospital