Esophageal AchalasiaNCT06405412
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
An observational study of Esophageal Achalasia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- MUST malnutrition score
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this retrospective cohort study, 50 patients diagnosed with achalasia who applied to the Gastroenterology department of Ümraniye Training and Research Hospital between October 2021 and February 2024 and were indicated for POEM treatment will be included.
Who may be able to join
- Criteria for inclusion in the study:
- Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
- ASA 1-3
- Between the ages of 18-80
Who cannot join
- Criteria for exclusion from the study:
- Those with a known history of active lung infection, advanced COPD, or respiratory failure
- Patients with EF below 40%, severe ischemic heart failure, presence of valve disease
- Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)
- severe kidney dysfunction
- In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both
Show all 11Show fewer
- Pre-existing increased intracranial pressure
- Having a BMI >30
- Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus
- History of mucosal resection or ablation in the area where POEM will be applied
- Presence of cirrhosis and portal hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Education and Research hospital
Istanbul, 34764
Zeliha Tuncel, 0216 632 18 18, zelihalara@yahoo.com
Harika Duygu Ozer, 0216 632 18 18, harikaduyguozer@gmail.com
About this study
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.
Read the detailed description
The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.
The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.
- Conditions
- Esophageal Achalasia
- Being tested
- MUST malnutrition score
- Keywords
- Peroral Endoscopic Myotomy, anesthesia, Esophageal Achalasia
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUST malnutrition scoreOther
MUST malnutrition score
| Study group | Role | What they receive |
|---|---|---|
| Mild malnutrition | Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) Receives: Other: MUST malnutrition score | |
| Moderate malnutrition | Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) Receives: Other: MUST malnutrition score | |
| Severe malnutrition | Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) Receives: Other: MUST malnutrition score |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiorespiratory advers events
hypercapnia (above 45mmHg)
Measured: up to 12 weeks
postoperative renal complications
serum creatinine 0.3 mg/dL rise
Measured: up to 12 weeks
Secondary outcomes (2)
Malnutrition condition
serum albumin (3.4 to 5.4 g/dL)
Measured: up to 12 weeks
escart score
weight loss ( <5kg to10kg>)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405412
- Sponsor's protocol ID
- UERH-AR-ZT-09
- Status last verified
- Nov 2025
- First submitted
- 6 May 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
- ClinicalTrials.gov ID
- NCT06405412
- Acronym / sponsor ID
- UERH-AR-ZT-09
- Conditions
- Esophageal Achalasia
- Keywords
- Peroral Endoscopic Myotomy, anesthesia, Esophageal Achalasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.
Detailed description
The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.
The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild malnutrition | – | Other: MUST malnutrition scorePatients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) |
| Moderate malnutrition | – | Other: MUST malnutrition scorePatients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) |
| Severe malnutrition | – | Other: MUST malnutrition scorePatients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this retrospective cohort study, 50 patients diagnosed with achalasia who applied to the Gastroenterology department of Ümraniye Training and Research Hospital between October 2021 and February 2024 and were indicated for POEM treatment will be included.
Key inclusion criteria (4 listed)
- Criteria for inclusion in the study:
- Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
- ASA 1-3
- Between the ages of 18-80
Key exclusion criteria (11 listed)
- Criteria for exclusion from the study:
- Those with a known history of active lung infection, advanced COPD, or respiratory failure
- Patients with EF below 40%, severe ischemic heart failure, presence of valve disease
- Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)
- severe kidney dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUST malnutrition scoreMUST malnutrition score | Other | Mild malnutrition, Moderate malnutrition, Severe malnutrition |
Primary outcome
cardiorespiratory advers events
Time frame: up to 12 weeks
hypercapnia (above 45mmHg)
postoperative renal complications
Time frame: up to 12 weeks
serum creatinine 0.3 mg/dL rise
2 secondary outcomes
Malnutrition condition
Time frame: up to 12 weeks
escart score
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Achalasia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zeliha tuncel (05053577483, zelihalara@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiorespiratory advers events (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.