Clinical trial NCT02490111: Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer
Official title: Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2015-07-03
Enrollment: 521
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 19 years of age
* Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
* D1+ or D2 lymph node dissection
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* Written informed consent

Exclusion Criteria:

* Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
* Presence of gallstones on ultrasonography and/or CT
* History of previous cholecystectomy
* Patients undergoing pylorus-preserving gastrectomy
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* Patients with history of drug or alcohol abuse within 5 years ago

Primary outcomes:
measure: Proportion of patient developing gallstone at 12 month after gastrectomy
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
timeFrame: 3, 6 and 9 months
measure: Time to gallstone formation
timeFrame: 12 months
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul Natioanl University Bundang Hospital
state: Gyeonggi-do
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyeongsangnamdo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National university Chilgok Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National university hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
citation: Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501.