Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents

NCT ID: NCT01585662

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Pseudocyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naso-pancreatic tube

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

Group Type EXPERIMENTAL

EUS-guided pancreatic pseudocyst drainage

Intervention Type PROCEDURE

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

Stents

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

Group Type EXPERIMENTAL

EUS-guided pancreatic pseudocyst drainage

Intervention Type PROCEDURE

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

Interventions

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EUS-guided pancreatic pseudocyst drainage

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

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. The patient can't accept the endoscopic procedure.
2. The patient has blood coagulation dysfunction.
3. The patient has mental disorders.
4. The patient has mild or severe cardiorespiratory insufficiency.
5. The patient has hypertension and can't be controlled to safe level.
6. Diabetics whose blood sugar level can't be controlled to safe level.
7. Patients with alcohol dependence
8. Pregnant and lactating women.
9. The patients the investigator don't think suitable for this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiaoyin Zhang

OTHER

Sponsor Role lead

Responsible Party

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Xiaoyin Zhang

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wu Kaichun, MD,PhD

Role: STUDY_CHAIR

The forth military medical university

Locations

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Xijing Institute of digestive diseases

Xian City, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyin Zhang, MD,PhD

Role: CONTACT

86-29-84771540

Xin Wang, MD,PhD

Role: CONTACT

86-29-84771516

Facility Contacts

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Xiaoyin Zhang, MD,PhD

Role: primary

86-29-84771540

Xin Wang, MD,PhD

Role: backup

86-29-84771516

References

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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.

Reference Type BACKGROUND
PMID: 11023579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17055880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17454865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18226686 (View on PubMed)

Other Identifiers

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1111

Identifier Type: -

Identifier Source: org_study_id

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