NCT01585662

Brief Summary

EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. So, the investigators designed this prospective random comparing study to confirm the result.

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
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

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

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

2.9 years

First QC Date

April 19, 2012

Last Update Submit

April 24, 2012

Conditions

Pancreatic Pseudocyst

Keywords

EUSpancreatic pseudocystdrainage

Outcome Measures

Primary Outcomes (1)

  • recurrence rate of pancreatic pseudocyst

    12 months

Secondary Outcomes (1)

  • The complication rate

    12 months

Study Arms (2)

Naso-pancreatic tube

EXPERIMENTAL

The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method.

Procedure: EUS-guided pancreatic pseudocyst drainage

Stents

EXPERIMENTAL

The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst.

Procedure: EUS-guided pancreatic pseudocyst drainage

Interventions

EUS-guided pancreatic pseudocyst drainagePROCEDURE

EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.

Also known as: Naso-pancreatic drainage tube:8 Fren,made by Cook Company, Two pig tails- stents:5cm long,made by Cook Company
Naso-pancreatic tubeStents

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with ages from 18-80 years old.
  • The pseudocysts were formed more than 3 months.
  • The size of pseudocyst is more than 5 cm.
  • The patient has the symptoms related with the pseudocyst.
  • The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.
  • The consent form has been signed.

You may not qualify if:

  • The patient can't accept the endoscopic procedure.
  • The patient has blood coagulation dysfunction.
  • The patient has mental disorders.
  • The patient has mild or severe cardiorespiratory insufficiency.
  • The patient has hypertension and can't be controlled to safe level.
  • Diabetics whose blood sugar level can't be controlled to safe level.
  • Patients with alcohol dependence
  • Pregnant and lactating women.
  • The patients the investigator don't think suitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Institute of digestive diseases

Xian City, Shanxi, 710032, China

RECRUITING

Related Publications (4)

  • Baron TH, Wiersema MJ. EUS-guided transesophageal pancreatic pseudocyst drainage. Gastrointest Endosc. 2000 Oct;52(4):545-9. doi: 10.1067/mge.2000.108928. No abstract available.

    PMID: 11023579BACKGROUND

  • Seewald S, Thonke F, Ang TL, Omar S, Seitz U, Groth S, Zhong Y, Yekebas E, Izbicki J, Soehendra N. One-step, simultaneous double-wire technique facilitates pancreatic pseudocyst and abscess drainage (with videos). Gastrointest Endosc. 2006 Nov;64(5):805-8. doi: 10.1016/j.gie.2006.07.049.

    PMID: 17055880BACKGROUND

  • Lopes CV, Pesenti C, Bories E, Caillol F, Giovannini M. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol. 2007 Apr;42(4):524-9. doi: 10.1080/00365520601065093.

    PMID: 17454865BACKGROUND

  • Barthet M, Lamblin G, Gasmi M, Vitton V, Desjeux A, Grimaud JC. Clinical usefulness of a treatment algorithm for pancreatic pseudocysts. Gastrointest Endosc. 2008 Feb;67(2):245-52. doi: 10.1016/j.gie.2007.06.014.

    PMID: 18226686BACKGROUND

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic CystCystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Wu Kaichun, MD,PhD

    The forth military medical university

    STUDY CHAIR

Central Study Contacts

Xiaoyin Zhang, MD,PhD

CONTACT

86-29-84771540zhangxy@fmmu.edu.cn

Xin Wang, MD,PhD

CONTACT

86-29-84771516wangx@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 26, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

CN(1)