NCT06948474

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Aug 2024Jun 2026

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

March 24, 2025

Last Update Submit

April 21, 2025

Conditions

Whipple Operation

Keywords

Pancreatic CancerIPMN, PancreaticwhipplePancreaticoduodenectomyPeriampullary

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 month after surgery

Secondary Outcomes (1)

  • postoperative assessment of gastrointestinal functional recovery

    From surgery date through postoperative day 30.

Study Arms (3)

Dachengqi Decoction Experimental Group

EXPERIMENTAL

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 decoctionProcedure: modified gastrointestinal dual-lumen feeding tube

control group

PLACEBO COMPARATOR

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 tubeDrug: Normal Saline (0.9% NaCl)

Blank control group

NO INTERVENTION

No specific therapeutic intervention was indicated

Interventions

Dachengqi decoctionDRUG

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.

Dachengqi Decoction Experimental Group
modified gastrointestinal dual-lumen feeding tubePROCEDURE

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).

Dachengqi Decoction Experimental Groupcontrol group
Normal Saline (0.9% NaCl)DRUG

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.

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Intraductal Neoplasms

Interventions

dachengqi decoctionSaline Solution

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Hepatobiliary and Pancreatic Surgery, Clinical Professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 29, 2025

Study Start

August 1, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

CN(1)