NCT07781176

Brief Summary

Brief Summary (Plain Language) The purpose of this clinical trial is to evaluate and compare the effects of four different intervention measures on preventing and managing postoperative gastrointestinal dysfunction in patients with primary liver cancer. The four measures include herbal acupoint application, transcutaneous acupoint electrical stimulation, the combination of the above two acupoint stimulation methods, and routine clinical nursing. This study aims to provide scientific evidence for the clinical application of acupoint stimulation therapies in postoperative rehabilitation of liver cancer patients. The main research question of this study is whether acupoint stimulation interventions can effectively improve postoperative gastrointestinal recovery in primary liver cancer patients. The primary outcome measure is the time to first postoperative anal exhaust, which is a core indicator to reflect the recovery of gastrointestinal function after surgery. By comparing the differences in gastrointestinal recovery among the four groups, this trial will clarify the optimal acupoint intervention scheme to prevent and relieve postoperative gastrointestinal dysfunction in primary liver cancer patients, so as to improve patients' postoperative rehabilitation quality.

Trial Health

65
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Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Oct 2026

Status
not yet 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 Progress1%
Oct 2026Aug 2027

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first postoperative flatus

    Perioperative, from the end of surgery until the first postoperative flatus occurs

Secondary Outcomes (2)

  • Time to first defecation

    Perioperative

  • Incidence of postoperative gastrointestinal dysfunction

    Within 7 days after surgery

Other Outcomes (1)

  • Incidence and severity of postoperative intestinal obstruction

    Within 14 days after surgery

Study Arms (4)

Acupoint Application

EXPERIMENTAL
Other: Acupoint application

TAES

EXPERIMENTAL
Device: TAES

Combined Intervention

EXPERIMENTAL
Other: Combined Intervention

Routine Care

ACTIVE COMPARATOR
Other: routine care

Interventions

Patients receive standard postoperative routine nursing care only. No additional acupoint-related interventions are provided throughout the study period.

Routine Care

Intervention starts after the patient returns to the ward with stable vital signs on the surgery day. Herbal patches composed of Natrii Sulfas, Radix et Rhizoma Rhei, Fructus Aurantii Immaturus and Cortex Magnoliae Officinalis are applied to bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4). Each application lasts 6 hours, once a day until the first anal exhaust. Relevant observations are recorded during the process.

Acupoint Application
TAESDEVICE

Treatment begins on the surgery day when vital signs stabilize after returning to the ward. Electrodes are placed on bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4) for transcutaneous acupoint electrical stimulation with 2/100 Hz dense-disperse waves. Current ranges from 1 mA up to patient's maximum tolerance (no more than 10 mA), 30 minutes per session once daily. Treatment data is recorded accordingly.

TAES

Initiated after stable vital signs on the surgery day. Receive transcutaneous acupoint electrical stimulation first, then herbal acupoint application. The specific operation standards are the same as the above two groups, performed once daily until the first anal exhaust.

Combined Intervention

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with primary liver cancer scheduled for initial partial hepatectomy or laparoscopic partial hepatectomy.
  • Aged between 18 and 75 years old.
  • Clear consciousness and ability to communicate in writing.
  • Voluntary participation with signed informed consent.

You may not qualify if:

  • Patients receiving concurrent chemotherapy.
  • Patients with adhesive plaster allergy or allergic constitution.
  • Patients with local skin damage, infection or dermatitis at acupoint sites.
  • Patients with cognitive dysfunction.
  • Patients complicated with preoperative gastrointestinal dysfunction or with a history of gastrointestinal surgery.
  • Patients undergoing associating liver partition and portal vein ligation for staged hepatectomy (ALPPS).
  • Patients transferred to the intensive care unit (ICU) after surgery.
  • Patients with implanted cardiac pacemakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Wang MX. Effect of acupoint application during Chen period on gastrointestinal function recovery in patients with primary liver cancer after laparoscopic surgery[D]. Guangzhou University of Chinese Medicine, 2023.

    BACKGROUND
  • Shi XL, Li H, Bian LF, et al. Summary of best evidence for prevention and management of postoperative gastrointestinal dysfunction in patients with liver cancer. Journal of Enhanced Recovery After Surgery, 2024, 7 (4): 145-151.

    BACKGROUND
  • Li S, Liu KX, Deng XM, et al. Expert consensus on prevention and treatment of postoperative gastrointestinal dysfunction. International Journal of Anesthesiology and Resuscitation, 2021, 42 (11): 1133-1142.

    BACKGROUND
  • Expert Committee for the Guidelines for Diagnosis and Treatment of Primary Liver Cancer, Zhou J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition). Chinese Journal of Clinical Medicine, 2024, 31(2): 277-334.

    BACKGROUND
  • Cheng XN, Zhang X, Ji J, Zhou J. [Acupoints selection rules of acupuncture and moxibustion for promoting gastrointestinal function recovery after intestinal cancer surgery based on complex network analysis]. Zhen Ci Yan Jiu. 2024 Oct 25;49(10):1107-1120. doi: 10.13702/j.1000-0607.20230829. Chinese.

    PMID: 39433373BACKGROUND
  • Jiang T, Li J, Meng L, Wang J, Zhang H, Liu M. Effects of transcutaneous electrical acupoint stimulation on gastrointestinal dysfunction after gastrointestinal surgery: A meta-analysis. Complement Ther Med. 2023 May;73:102938. doi: 10.1016/j.ctim.2023.102938. Epub 2023 Feb 25.

    PMID: 36842636BACKGROUND
  • Arfa S, Turco C, Lakkis Z, Bourgeois S, Fouet I, Evrard P, Sennegon E, Roucoux A, Paquette B, Devaux B, Rietsch-Koenig A, Heyd B, Doussot A. Delayed return of gastrointestinal function after hepatectomy in an ERAS program: incidence and risk factors. HPB (Oxford). 2022 Sep;24(9):1560-1568. doi: 10.1016/j.hpb.2022.03.014. Epub 2022 Apr 5.

    PMID: 35484074BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yan Zhu

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhu, Master of Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share