Clinical trial NCT01585662: Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents
Official title: Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatic Pseudocyst
Keywords: EUS
pancreatic pseudocyst
drainage
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: recurrence rate of pancreatic pseudocyst
timeFrame: 12 months
Secondary outcomes:
measure: The complication rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Xian city
country: China
facility: Xijing Institute of digestive diseases
state: Shanxi
Study officials:
affiliation: The forth military medical university
name: Wu Kaichun, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.