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Trial record 61 of 761 for:    region | Chile

Pancreaticobiliary Reflux in Patients Without Cholelithiasis

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ClinicalTrials.gov Identifier: NCT00890201
Recruitment Status : Completed
First Posted : April 29, 2009
Results First Posted : October 20, 2009
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
Cirujanos la Serena

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Pancreaticobiliary Reflux
Intervention Procedure: Gallbladder bile sampling and intraoperative cholangiography
Enrollment 197
Recruitment Details Patients recruited at the Department of Surgery of the Hospital de La Serena from January 2009 to July 2009
Pre-assignment Details 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
Arm/Group Title Normal Gallbladder Gallbladder With Gallstones
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 38 [1] 159 [2]
Completed 33 [3] 103 [4]
Not Completed 5 56
Reason Not Completed
Protocol Violation             5             56
[1]
5 patients with gastric cancer and gallstone disease
[2]
41 patients with acute cholecystitis and 15 patients with common bile duct stones
[3]
33 patients with gastric cancer and without gallstone disease
[4]
103 patients without acute cholecystitis or common bile duct stones
Arm/Group Title Normal Gallbladder Gallbladder With Gallstones Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 38 159 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 159 participants 197 participants
<=18 years
0
   0.0%
2
   1.3%
2
   1.0%
Between 18 and 65 years
33
  86.8%
149
  93.7%
182
  92.4%
>=65 years
5
  13.2%
8
   5.0%
13
   6.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 159 participants 197 participants
55.4  (10) 43.4  (12.6) 46.3  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 159 participants 197 participants
Female
21
  55.3%
19
  11.9%
40
  20.3%
Male
17
  44.7%
140
  88.1%
157
  79.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 38 participants 159 participants 197 participants
38 159 197
1.Primary Outcome
Title Amylase and Lipase Values in Gallbladder Bile
Hide Description Normal values of lipase and amylase in gallbladder bile should be zero
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Normal Gallbladder Gallbladder With Gallstones
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 103
Mean (Standard Deviation)
Unit of Measure: mg/dl
Amylase 5.5  (16.4) 181.2  (352)
Lipase 9.5  (16.6) 434.8  (1224)
2.Secondary Outcome
Title Amylase and Lipase Values in Normal Gallbladders
Hide Description [Not Specified]
Time Frame 24 hours
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Amylase and Lipase Values in Gallbladders With Cholelithiasis
Hide Description [Not Specified]
Time Frame 24 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Normal Operative Cholangiography
Hide Description [Not Specified]
Time Frame 24 hours
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Normal Preoperative Serum Values of Amylase and Lipase
Hide Description [Not Specified]
Time Frame 24 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed
 
Arm/Group Title Normal Gallbladder Gallbladder With Gallstones
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Normal Gallbladder Gallbladder With Gallstones
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Gallbladder Gallbladder With Gallstones
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Normal Gallbladder Gallbladder With Gallstones
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Marcelo A. Beltran, M.D. - Department of Surgery - Hospital de La Sererna
Organization: Hospital de La Serena
Phone: 56 51 485923
Responsible Party: MARCELO A. BELTRAN, M.D., HOSPITAL DE LA SERENA
ClinicalTrials.gov Identifier: NCT00890201     History of Changes
Other Study ID Numbers: HLS-2704009-02
First Submitted: April 28, 2009
First Posted: April 29, 2009
Results First Submitted: July 27, 2009
Results First Posted: October 20, 2009
Last Update Posted: December 17, 2010