Clinical trial NCT03373682: Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis
Official title: Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Geriatric Patients With Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Geriatric
Extracorporeal Shock Wave Lithotripsy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 1404
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic pancreatitis patients with pancreatic stones in China

Brief summary: Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is recommended as the first-line treatment for pancreatic stones. However, how well P-ESWL performs in geriatric patients remains unclear. The investigators aimed to evaluate the safety and efficacy of P-ESWL for geriatric patients with chronic pancreatitis.

Detailed description: This prospective observational study was conducted in patients with painful chronic pancreatitis who underwent P-ESWL. Patients aged over 65 years were included in the geriatric group; patients aged under 65 years who underwent P-ESWL in the same period were assigned to the control group. For investigation of long-term follow-up, the geriatric group were matched with patients from the control group in a 1:1 ratio. The primary outcomes were P-ESWL complications and pain relief. The secondary outcomes included: stone clearance, physical and mental health, quality of life score, and body weight.

Eligibility criteria: Inclusion Criteria:

* Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.

Exclusion Criteria:

* Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.

Primary outcomes:
measure: P-ESWL complications
timeFrame: April 30, 2016
measure: Pain relief by the end of follow-up period
timeFrame: April 30, 2018
Secondary outcomes:
measure: Stone clearance as assessed by ERCP performed post-ESWL
timeFrame: April 30, 2016
measure: Physical and mental health assessed by SF-36 questionnaire
timeFrame: April 30, 2018
measure: Quality of life score assessed by the patient
timeFrame: April 30, 2018
measure: Body weight
timeFrame: April 30, 2018
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
citation: Wang D, Bi YW, Ji JT, Xin L, Pan J, Liao Z, Du TT, Lin JH, Zhang D, Zeng XP, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Li ZS, Hu LH. Extracorporeal shock wave lithotripsy is safe and effective for pediatric patients with chronic pancreatitis. Endoscopy. 2017 May;49(5):447-455. doi: 10.1055/s-0043-104527. Epub 2017 Apr 12.
citation: Hu LH, Ye B, Yang YG, Ji JT, Zou WB, Du TT, Hao JF, Jiang YY, Liao Z, Li ZS. Extracorporeal Shock Wave Lithotripsy for Chinese Patients With Pancreatic Stones: A Prospective Study of 214 Cases. Pancreas. 2016 Feb;45(2):298-305. doi: 10.1097/MPA.0000000000000464.
citation: Li BR, Liao Z, Du TT, Ye B, Chen H, Ji JT, Zheng ZH, Hao JF, Ning SB, Wang D, Lin JH, Hu LH, Li ZS. Extracorporeal shock wave lithotripsy is a safe and effective treatment for pancreatic stones coexisting with pancreatic pseudocysts. Gastrointest Endosc. 2016 Jul;84(1):69-78. doi: 10.1016/j.gie.2015.10.026. Epub 2015 Nov 2.
citation: Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24.