Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04098120 |
| Other study ID # |
upper endoscopy in CKD&ESRD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
November 1, 2021 |
Study information
| Verified date |
September 2019 |
| Source |
Assiut University |
| Contact |
nada abdelsalam hasan, doctor |
| Phone |
01003562354 |
| Email |
nadaabdelsalam63[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage
III---V) and haemodialyzed patients with upper GIT symptoms
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
