Symptoms and SignsNCT04152902
Quality of Life After Surgery for End-stage Achalasia
An observational study of Symptoms and Signs and Quality of Life, run by University of Bologna at 1 site in Italy.
Trial summary
Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptoms and Signs, Quality of Life
- What is being tested?
- Objective outcome and Quality of life
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1987to Jun 2019
- How long will I take part?
- 70 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary referral center
Who may be able to join
- follow-up longer than 1 year
- preoperative and postoperative endoscopy available
- preoperative and postoperative barium swallow available
- preoperative and postoperative manometry available
Who cannot join
- patients undergone chemotherapy
- patients with relapse of disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Surgery for End-stage Achalasia: Pull-down Heller-Dor vs Esophagectomy
Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy.
The study included 31 patients (57 years) who underwent the Heller-Dor procedure with verticalisation of the distal oesophagus (pull-down technique dedicated to sigmoid oesophagus treatment) and 29 patients (recurrence free, 64 years) (p=0.539) who underwent oesophagectomy for end-stage achalasia or for cancer, extracted from a database designed for prospective clinical research. The objective outcomes of treatment were evaluated with semi-quantitative scales investigating dysphagia, reflux symptoms and endoscopic oesophagitis. Quality of life was assessed with the SF-36 questionnaire.
Read the detailed description
Patients were extracted from a database designed for prospective clinical research on benign and malignant oesophageal diseases. For this study, the investigators considered patients who underwent operations for end-stage achalasia from January 1987-July 2018 and patients who survived after primary esophagectomy for oesophageal cancer between January 2008 and December 2018 without undergoing neoadjuvant/adjuvant therapy. End-stage achalasia was diagnosed on the basis of clinical history, upper gastrointestinal tract endoscopy and barium swallow results (oesophageal diameter larger than 6 cm, distal oesophagus kinked towards the left side, outside the axis). Standard oesophageal manometry, or more recently, high-resolution manometry, was routinely performed. Cases of pseudo-achalasia (oesophageal dilation secondary to organic stenosis of the cardia) were excluded based on clinical, endoscopic and histology patterns. In the presence of end-stage achalasia Pull-down Heller-Dor was the first primary treatment option for patients with the following: a) no severe mucosal inflammation or moderate/high grade dysplasia and b) redo surgery exclusively for dysphagia relapse due to insufficient myotomy. Esophagectomy was the treatment of choice for patients with the following: a) relapsed dysphagia after myotomy due to scarring that caused stenosis of the cardia, b) iterative surgery, c) cancerization risk patterns, and d) a diagnosis of cancer.
The pull-down Helle-Dor procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The pull-down Heller-Dor operation was performed under manometric control.
Esophagectomy was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus. Patients who underwent esophagectomy for cancer not related to achalasia were extracted from the relative case series to form a control group that matched the end-stage achalasia study group according to age and surgical technique; these patients had not undergone neoadjuvant or adjuvant chemotherapy and were cancer free at follow-up.
The duration of achalasia symptoms was calculated starting from the date of onset to the date of surgery at the investigator's institution. After surgery, the patients underwent a timed follow-up composed of clinical interviews, upper GI tract barium swallow and endoscopy. The symptoms were evaluated according to semi-quantitative scales graded from 0 (absence) to 3 (maximal intensity) based on Van Trappen's criteria for dysphagia and Visick's criteria for gastro-oesophageal reflux. Upper GI endoscopy aimed to detect post Heller's myotomy reflux oesophagitis, Barrett's oesophagus and areas suspected for dysplasia or cancer. Reflux oesophagitis was initially assessed according to the Savary-Miller and Ismail Beigi criteria and successively assessed according to the Los Angeles classification. The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis.
Quality of life was assessed by the version of the 36-Item Short Form Survey (SF-36) validated for Italy. The questionnaire was a generic Health-Related Quality of Life (HRQL) measure that investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poor HRQL) to 100 (best HRQL). Patients self-administered the questionnaires they received in mail for the specific purpose of this study.
- Conditions
- Symptoms and Signs, Quality of Life
- Being tested
- Objective outcome, Quality of life
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective outcomeOther
The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis
Quality of lifeOther
SF-36 Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| PULL-DOWN HELLER-DOR | The PD-HD procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication according to Dor, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The PD-HD operation was performed under manometric control Receives: Other: Objective outcome; Other: Quality of life | |
| OESOPHAGECTOMY | OE was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus Receives: Other: Objective outcome; Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of dysphagia severity from preoperative to 3 years after surgery
changing of dysphagia severity from preoperative to 3 years after surgery. Dysphagia severity is evaluted according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria
Measured: 3 years
change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey
change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey. Severity of reflux symptoms was evaluated according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria
Measured: 3 years
change quality of life from preoperative to 3 years after surgery
change quality of life from preoperative to 3 years after surgery. The SF-36 questionnaire investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poorer HRQL) to 100 (best HRQL).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startJan 1987
- Primary completionJul 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 70 Months
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Mattioli, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152902
- Sponsor's protocol ID
- ESA
- Status last verified
- Nov 2019
- First submitted
- 19 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Surgery for End-stage Achalasia: Pull-down Heller-Dor vs Esophagectomy
- ClinicalTrials.gov ID
- NCT04152902
- Acronym / sponsor ID
- ESA
- Conditions
- Symptoms and Signs, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 1987 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 Nov 2019 (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.
Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy.
The study included 31 patients (57 years) who underwent the Heller-Dor procedure with verticalisation of the distal oesophagus (pull-down technique dedicated to sigmoid oesophagus treatment) and 29 patients (recurrence free, 64 years) (p=0.539) who underwent oesophagectomy for end-stage achalasia or for cancer, extracted from a database designed for prospective clinical research. The objective outcomes of treatment were evaluated with semi-quantitative scales investigating dysphagia, reflux symptoms and endoscopic oesophagitis. Quality of life was assessed with the SF-36 questionnaire.
Detailed description
Patients were extracted from a database designed for prospective clinical research on benign and malignant oesophageal diseases. For this study, the investigators considered patients who underwent operations for end-stage achalasia from January 1987-July 2018 and patients who survived after primary esophagectomy for oesophageal cancer between January 2008 and December 2018 without undergoing neoadjuvant/adjuvant therapy. End-stage achalasia was diagnosed on the basis of clinical history, upper gastrointestinal tract endoscopy and barium swallow results (oesophageal diameter larger than 6 cm, distal oesophagus kinked towards the left side, outside the axis). Standard oesophageal manometry, or more recently, high-resolution manometry, was routinely performed. Cases of pseudo-achalasia (oesophageal dilation secondary to organic stenosis of the cardia) were excluded based on clinical, endoscopic and histology patterns. In the presence of end-stage achalasia Pull-down Heller-Dor was the first primary treatment option for patients with the following: a) no severe mucosal inflammation or moderate/high grade dysplasia and b) redo surgery exclusively for dysphagia relapse due to insufficient myotomy. Esophagectomy was the treatment of choice for patients with the following: a) relapsed dysphagia after myotomy due to scarring that caused stenosis of the cardia, b) iterative surgery, c) cancerization risk patterns, and d) a diagnosis of cancer.
The pull-down Helle-Dor procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The pull-down Heller-Dor operation was performed under manometric control.
Esophagectomy was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus. Patients who underwent esophagectomy for cancer not related to achalasia were extracted from the relative case series to form a control group that matched the end-stage achalasia study group according to age and surgical technique; these patients had not undergone neoadjuvant or adjuvant chemotherapy and were cancer free at follow-up.
The duration of achalasia symptoms was calculated starting from the date of onset to the date of surgery at the investigator's institution. After surgery, the patients underwent a timed follow-up composed of clinical interviews, upper GI tract barium swallow and endoscopy. The symptoms were evaluated according to semi-quantitative scales graded from 0 (absence) to 3 (maximal intensity) based on Van Trappen's criteria for dysphagia and Visick's criteria for gastro-oesophageal reflux. Upper GI endoscopy aimed to detect post Heller's myotomy reflux oesophagitis, Barrett's oesophagus and areas suspected for dysplasia or cancer. Reflux oesophagitis was initially assessed according to the Savary-Miller and Ismail Beigi criteria and successively assessed according to the Los Angeles classification. The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis.
Quality of life was assessed by the version of the 36-Item Short Form Survey (SF-36) validated for Italy. The questionnaire was a generic Health-Related Quality of Life (HRQL) measure that investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poor HRQL) to 100 (best HRQL). Patients self-administered the questionnaires they received in mail for the specific purpose of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 70 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PULL-DOWN HELLER-DOR | – | Other: Objective outcome, Other: Quality of lifeThe PD-HD procedure aimed to restore the vertical axis of the intraabdominal portion of the oesophagus as much as possible. In brief, before performing the myotomy and the anterior fundoplication according to Dor, at least 6 cm of the mediastinal oesophagus was fully isolated; two or more U intramuscular stitches were applied on the curling of the right side of the oesophagus, pulled down and rotated towards the right side of the gastro-oesophageal junction. The PD-HD operation was performed under manometric control |
| OESOPHAGECTOMY | – | Other: Objective outcome, Other: Quality of lifeOE was performed with open technique, or recently, with a minimally invasive technique. The stomach was always the oesophageal substitute, and the oesophagogastric anastomosis was preferably located at the thoracic dome or at the neck to minimize the risk of postoperative reflux oesophagitis or cancer growth in the residual dilated oesophagus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary referral center
Key inclusion criteria (4 listed)
- follow-up longer than 1 year
- preoperative and postoperative endoscopy available
- preoperative and postoperative barium swallow available
- preoperative and postoperative manometry available
Key exclusion criteria (2 listed)
- patients undergone chemotherapy
- patients with relapse of disease
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 |
|---|---|---|
| Objective outcomeThe final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis | Other | OESOPHAGECTOMY, PULL-DOWN HELLER-DOR |
| Quality of lifeSF-36 Questionnaire | Other | OESOPHAGECTOMY, PULL-DOWN HELLER-DOR |
Primary outcome
change of dysphagia severity from preoperative to 3 years after surgery
Time frame: 3 years
changing of dysphagia severity from preoperative to 3 years after surgery. Dysphagia severity is evaluted according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria
change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey
Time frame: 3 years
change of gastroesphageal reflux symptoms from preoperative to 3 years after surgey. Severity of reflux symptoms was evaluated according to a semiquantitative scale graded from 0 (absence) to 3 ( maximal intensity) based on Van Trappen's criteria
change quality of life from preoperative to 3 years after surgery
Time frame: 3 years
change quality of life from preoperative to 3 years after surgery. The SF-36 questionnaire investigated eight specific health domains: physical functioning (PF), restrictions in activities due to physical (RP) or emotional health (RE), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and social functioning (SF). The SF-36 scores for each health domain ranged from 0 (poorer HRQL) to 100 (best HRQL).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Symptoms and Signs and Quality of Life, run by University of Bologna at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 5 Nov 2019. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of dysphagia severity from preoperative to 3 years after surgery (time frame: 3 years). The study lists 3 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 5 Nov 2019.