Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-20 @ 3:45 PM
Study NCT ID:
NCT04098120
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Endoscopy in CKD&ESRD
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients In Assiut University Hospitals
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage III---V) and haemodialyzed patients with upper GIT symptoms
Detailed Description:
Chronic Kidney disease (CKD) is Kidney damage for ≥3 months, as defined by structural \&or functional abnormalities of the kidney, with or without decreased GFR or GFR \<60 mL/min/1.73m2 for ≥3 months, with or without kidney damage.
Stage Description GFR (ml/min/1.73 m2) Stage I Kidney damage \>90 with normal or ↑ GFR Stage II Kidney damage with 60-89 mild ↓ in GFR Stage III Moderate ↓ in GFR 30-59 Stage IV Severe ↓ in GFR 15-29 Stage V Kidney failure \< 15 \< 15 (or dialysis) Or on dialysis
\- CKD virtually affect the functions of all systems in our human body and associated with several deleterious effects on different systems which is due to multiple risk factors and associated with several abnormalities in the gastrointestinal tract involving all its segments, which include : Esophagitis: is present in more than a the third of the third of cases of uremic patients. It is due to increase of intra-abdominal pressure and reflux. The treatment of these patients is not different from that given to the general population with proton pump inhibitors, once the endoscopic study has been done.
Gastritis and peptic ulcer:as In patients with CKD and haemodialyzed patients, serum levels of gastrin are increased due to increased its secretion and decrease its excretion as it is eliminated by the kidney; additionally, cholecystokinin and secretin may be elevated. Noninvasive tests (H. pylori) have lower sensitivity in CKD so upper endscopy is needed.
In CKD and ESRD patients have more symptoms than general population.Specifically, gastrointestinal distress symptoms and peptic ulcers . The recurrence of peptic ulcer disease (PUD) after Helicobacter pylori eradication is higher in uremic patients than in non-uremic patients, and patients with ESRD have higher complication rates after ulcer development . Therefore, upper endoscopy should be performed in patients with these risk factors more often to prevent severe complications, such as gastrointestinal bleeding ( Haematemesis and melena). Angiodysplasia: affects the microcirculation of the mucosa and sub mucosa of the entire gastrointestinal tract. It is a frequent cause of bleeding in elderly patients, and its incidence is increased in patients on dialysis. Which diagnosed mainly by upper endoscopy as well as for the treatment with hemostasis techniques. The other option is angiography embolization, .
The manifestations of GIT in patients with chronic kidney disease and haemodialyzed patients varies from anorexia,nausea, vomiting they have aprevalance of around 60% )and GIT bleeding and viral hepatitis so it is across sectional study on 60 patients including CKD stage(III---V)and haemodialyzed patients.
* All patients will be subjected to :
* Full history and clinical examination . 2) Laboratory tests:
1. CBC .
2. liver function testes including PT,PC,INR
3. blood urea and serum creatinine.
4. serum calcium and phosphorus
5. urine analysis. 3) abdominal ultrasonography 4) upper endoscopy
Stage Description GFR (ml/min/1.73 m2) Stage I Kidney damage \>90 with normal or ↑ GFR Stage II Kidney damage with 60-89 mild ↓ in GFR Stage III Moderate ↓ in GFR 30-59 Stage IV Severe ↓ in GFR 15-29 Stage V Kidney failure \< 15 \< 15 (or dialysis) Or on dialysis
\- CKD virtually affect the functions of all systems in our human body and associated with several deleterious effects on different systems which is due to multiple risk factors and associated with several abnormalities in the gastrointestinal tract involving all its segments, which include : Esophagitis: is present in more than a the third of the third of cases of uremic patients. It is due to increase of intra-abdominal pressure and reflux. The treatment of these patients is not different from that given to the general population with proton pump inhibitors, once the endoscopic study has been done.
Gastritis and peptic ulcer:as In patients with CKD and haemodialyzed patients, serum levels of gastrin are increased due to increased its secretion and decrease its excretion as it is eliminated by the kidney; additionally, cholecystokinin and secretin may be elevated. Noninvasive tests (H. pylori) have lower sensitivity in CKD so upper endscopy is needed.
In CKD and ESRD patients have more symptoms than general population.Specifically, gastrointestinal distress symptoms and peptic ulcers . The recurrence of peptic ulcer disease (PUD) after Helicobacter pylori eradication is higher in uremic patients than in non-uremic patients, and patients with ESRD have higher complication rates after ulcer development . Therefore, upper endoscopy should be performed in patients with these risk factors more often to prevent severe complications, such as gastrointestinal bleeding ( Haematemesis and melena). Angiodysplasia: affects the microcirculation of the mucosa and sub mucosa of the entire gastrointestinal tract. It is a frequent cause of bleeding in elderly patients, and its incidence is increased in patients on dialysis. Which diagnosed mainly by upper endoscopy as well as for the treatment with hemostasis techniques. The other option is angiography embolization, .
The manifestations of GIT in patients with chronic kidney disease and haemodialyzed patients varies from anorexia,nausea, vomiting they have aprevalance of around 60% )and GIT bleeding and viral hepatitis so it is across sectional study on 60 patients including CKD stage(III---V)and haemodialyzed patients.
* All patients will be subjected to :
* Full history and clinical examination . 2) Laboratory tests:
1. CBC .
2. liver function testes including PT,PC,INR
3. blood urea and serum creatinine.
4. serum calcium and phosphorus
5. urine analysis. 3) abdominal ultrasonography 4) upper endoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: