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

Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Pseudocyst
• Intervention / Treatment: Procedure: EUS-guided pancreatic pseudocyst drainage

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoyin Zhang, MD,PhD; Phone Number: 86-29-84771540; Email: zhangxy@fmmu.edu.cn
• Study Contact Backup: Name: Xin Wang, MD,PhD; Phone Number: 86-29-84771516; Email: wangx@fmmu.edu.cn

Study Locations

• China
  • Shanxi
    • Xian city, Shanxi, China, 710032
      • Recruiting
      • Xijing Institute of digestive diseases
      • Contact: Xiaoyin Zhang, MD,PhD; Phone Number: 86-29-84771540; Email: zhangxy@fmmu.edu.cn
      • Contact: Xin Wang, MD,PhD; Phone Number: 86-29-84771516; Email: wangx@fmmu.edu.cn
      • Principal Investigator: Xiaoyin Zhang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Naso-pancreatic tube; The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method.	Procedure: EUS-guided pancreatic pseudocyst drainage; EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.; Other Names: Naso-pancreatic drainage tube:8 Fren,made by Cook Company; Two pig tails- stents:5cm long,made by Cook Company
EXPERIMENTAL: Stents; 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; EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.; Other Names: Naso-pancreatic drainage tube:8 Fren,made by Cook Company; Two pig tails- stents:5cm long,made by Cook Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence rate of pancreatic pseudocyst	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The complication rate	12 months

Collaborators and Investigators

• Sponsor: Xiaoyin Zhang
• Investigators: Study Chair: Wu Kaichun, MD,PhD, The forth military medical university

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 24, 2012
• First Posted (ESTIMATE): April 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 24, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: EUS; drainage; pancreatic pseudocyst
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Pseudocyst
• Other Study ID Numbers: 1111