NCT04255095

Brief Summary

The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

January 30, 2020

Last Update Submit

February 2, 2020

Conditions

ERCP

Keywords

Pancreatic duct negative-pressure suction

Outcome Measures

Primary Outcomes (2)

  • Rehabilitation

    time from ERCP to ischarge

    2 months

  • complication rate

    Pancreatitis aggravation， hemorrhage，fistula

    1 months

Secondary Outcomes (2)

  • LOS(length of stay)

    postoperative period（1 month ）

  • death rate

    postoperative period（1 month ）

Study Arms (2)

Nasobiliary drainage

ACTIVE COMPARATOR
Procedure: control

Naso-pancreatic drainage(negative pressure)

EXPERIMENTAL
Procedure: experiment

Interventions

experimentPROCEDURE

Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。

Also known as: Naso-pancreatic duct negative pressure attraction
Naso-pancreatic drainage(negative pressure)
controlPROCEDURE

Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。

Also known as: naso-biliary drinage
Nasobiliary drainage

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.
  • Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.

You may not qualify if:

  • Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Central Study Contacts

Qiong Gong, Doctor

CONTACT

+8618086496360gongq2019@163.com

Z'hong'chao Zhu, Doctor

CONTACT

+8613995617151

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

October 1, 2019

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

CN(1)