NCT02279147

Brief Summary

RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation. PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

September 22, 2014

Last Update Submit

October 28, 2014

Conditions

Systemic Inflammatory Response SyndromeJaundice, Obstructive

Keywords

Systemic Inflammatory Response SyndromeJaundice, Obstructiveanti-inflammatory

Outcome Measures

Primary Outcomes (1)

  • C reactive protein

    Indicator of the stress level.

    One year

Secondary Outcomes (15)

  • Temperature

    One year

  • Heart rate

    One year

  • Respiratory

    One year

  • PaCO2

    One year

  • White blood cell count

    one year

  • +10 more secondary outcomes

Study Arms (2)

raceanisodamine & neostigmine

EXPERIMENTAL

Patients receive immediately raceanisodamine（10mg）by intramuscular injection after operation.Then the patients will be receive 50mg raceanisodamine and 0.15mg neostigmine within 24hs by slow injection into vein for three consecutive days.

Drug: neostigmine methylsulfate，raceanisodamine hydrochloride

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NO INTERVENTION

Patients do not receive special treatment after operation.

Interventions

neostigmine methylsulfate，raceanisodamine hydrochlorideDRUG

The patients receive immediately raceanisodamine hydrochloride(10mg) by intramuscular injection after operation .From that date, for three consecutive days, the patients will be receive 50mg raceanisodamine hydrochloride and 0.15mg neostigmine methylsulfate in the 24h by slow injection of vein.

raceanisodamine & neostigmine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ⅰ.Accompanied by obstructive jaundice and plans to implement the liver resection of hilar bile duct carcinoma.
  • Patients with carcinoma of head of pancreas and plans to implement pancreaticoduodenectomy.
  • Ⅱ. Drugs which were used in the clinical trials is safe for patients.
  • Ⅲ.The patients did not occur the complication which would affect the experimental observation seriously after the operation.
  • Ⅳ.The patients agreed to participate in this clinical trial and sign the informed consent.

You may not qualify if:

  • Ⅰ.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.
  • Ⅱ.Patients with tumor metastases widely or can not accept a predetermined operation scheme.
  • Ⅲ. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHN Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeJaundice, Obstructive

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockJaundiceHyperbilirubinemiaSkin ManifestationsSigns and Symptoms

Study Officials

  • GU wanqing

    CHN Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Wanqing GU, MD

CONTACT

+86-10-6693833413366779198@163.com

Yurong LIANG, MD

CONTACT

+86-10-66938334yurongliang@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 30, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

CN(1)