Skip to content

Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis

Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255095
Enrollment
80
Registered
2020-02-05
Start date
2019-10-01
Completion date
2021-06-01
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERCP

Keywords

Pancreatic duct negative-pressure suction

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.

Detailed description

This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment. Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

Interventions

PROCEDUREexperiment

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

PROCEDUREcontrol

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

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Rehabilitation2 monthstime from ERCP to ischarge
complication rate1 monthsPancreatitis aggravation, hemorrhage,fistula

Secondary

MeasureTime frameDescription
LOS(length of stay)postoperative period(1 month )time from operation to discharge
death ratepostoperative period(1 month )Mortality from the disease

Countries

China

Contacts

Primary ContactQiong Gong, Doctor
gongq2019@163.com+8618086496360
Backup ContactZ'hong'chao Zhu, Doctor
+8613995617151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026