Trial Outcomes & Findings for Pancreaticobiliary Reflux in Patients Without Cholelithiasis (NCT NCT00890201)

NCT ID: NCT00890201

Last Updated: 2010-12-17

Results Overview

Normal values of lipase and amylase in gallbladder bile should be zero

• Recruitment status: COMPLETED
• Target enrollment: 197 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2010-12-17

Participant Flow

Patients recruited at the Department of Surgery of the Hospital de La Serena from January 2009 to July 2009

Patients submitted to elective cholecystectomy for symptomatic gallstone disease, older than 16 years of age and patients submitted to elective gastrectomy for gastric cancer harboring normal gallbladders (without gallstones), were included in this trial. Patients within any other clinical situation were excluded

Participant milestones

Measure	Normal Gallbladder Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal.	Gallbladder With Gallstones Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.
Overall Study STARTED	38	159
Overall Study COMPLETED	33	103
Overall Study NOT COMPLETED	5	56

Reasons for withdrawal

Measure	Normal Gallbladder Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal.	Gallbladder With Gallstones Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.
Overall Study Protocol Violation	5	56

Baseline Characteristics

Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Baseline characteristics by cohort

Measure	Normal Gallbladder n=38 Participants Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal.	Gallbladder With Gallstones n=159 Participants Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.	Total n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	149 Participants n=7 Participants	182 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Age Continuous	55.4 years STANDARD_DEVIATION 10 • n=5 Participants	43.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	46.3 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	140 Participants n=7 Participants	157 Participants n=5 Participants
Region of Enrollment Chile	38 participants n=5 Participants	159 participants n=7 Participants	197 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.

Normal values of lipase and amylase in gallbladder bile should be zero

Outcome measures

Measure	Normal Gallbladder n=33 Participants Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal.	Gallbladder With Gallstones n=103 Participants Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound). The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal.
Amylase and Lipase Values in Gallbladder Bile Amylase	5.5 mg/dl Standard Deviation 16.4	181.2 mg/dl Standard Deviation 352
Amylase and Lipase Values in Gallbladder Bile Lipase	9.5 mg/dl Standard Deviation 16.6	434.8 mg/dl Standard Deviation 1224

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

Adverse Events

Normal Gallbladder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gallbladder With Gallstones

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcelo A. Beltran, M.D. - Department of Surgery - Hospital de La Sererna

Hospital de La Serena

Phone: 56 51 485923

Email: beltran_01@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place