ESWL Versus ESWL and Endoscopic Treatment

NCT02971475 | Unknown DMC

• 1 other identifier: 20160801
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.

Conditions

Pancreatitis

Keywords

Extracorporeal Shock Wave lithotripsy(ESWL); Endoscopic Retrograde Cholangiopancreatography(ERCP); chronic pancreatitis; pain relief

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain score as accessed by izbichi pain score at 12 month

  Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.

  12 months

Secondary Outcomes (3)

• exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit

  12 months

• clearance of pancreatic stones

  12 months

• decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP

  12 months

Other Outcomes (5)

• complication rate

  1 months

• endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin

  12 months

• treatment-related cost from initial treatment to the end of the study(12 months)

  12 months

Study Arms (2)

ESWL alone

EXPERIMENTAL

Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded.

Procedure: extracorporeal shock wave lithotripsy; Drug: Analgesics

ESWL combined with ERCP

ACTIVE COMPARATOR

People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded.

Procedure: endoscopic drainage of the main pancreatic duct; Drug: Analgesics

Interventions

extracorporeal shock wave lithotripsy PROCEDURE

People in this group would be treated with ESWL only.

Also known as: ESWL

ESWL alone

endoscopic drainage of the main pancreatic duct PROCEDURE

People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.

Also known as: ERCP

ESWL combined with ERCP

Analgesics DRUG

Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.

ESWL alone; ESWL combined with ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
• at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
• no ERCP or ESWL carried out before admission

You may not qualify if:

• suspected to have malignant tumors;
• history of pancreatic surgery or gastrojejunostomy (Billroth II);
• pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
• age below 18 years;
• pregnancy or lactation;
• refuse to write informed consent

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic

Interventions

Lithotripsy; Cholangiopancreatography, Endoscopic Retrograde; Analgesics

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Zhao-shen Li

CONTACT

zhaoshen-li@hotmail.com

Zhuan Liao

CONTACT

liaozhuan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)