Upper Gastrointestinal Submucosal Tumors (SMTs)NCT01768104
ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors
A study testing ESTD and VATS in people with Upper Gastrointestinal Submucosal Tumors (SMTs) and Gastrointestinal Stromal Tumors (GISTs), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Upper Gastrointestinal Submucosal Tumors (SMTs), Gastrointestinal Stromal Tumors (GISTs), Leiomyoma
- What is being tested?
- ESTD and VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between 18 and 75 years of age
- Patient with upper gastrointestinal submucosal tumor
- Signed informed consent
Who cannot join
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Mega-oesophagus (greater than 7 cm) or Oesophageal diverticula in the distal oesophagus
- Previous oesophageal or gastric surgery
- Pregnancy or lactation women, or ready to pregnant women
- Not capable of filling out questionnaires
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Xiaobing Cui, M.D., +86 13631312723, xbing119@gmail.com
About this study
Official title: Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
The purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors.
Read the detailed description
Most upper gastrointestinal submucosal tumors (SMTs), especially the gastrointestinal stromal tumors (GISTs) and leiomyoma, are regarded as benign if they are less than 3cm in size. Thus, it has been suggested that patients should receive periodic endoscopic follow-up in case of gradual changes in size; however this can be stressful and troublesome for patients. Nevertheless, some of these tumors do have a malignant potential, and management by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. Therefore, it is necessary to remove the SMTs.
To date, several approaches have been used for the treatment of upper gastrointestinal SMTs, including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as band ligation, endoscopic submucosal dissection (ESD), and endoscopic full-thickness resection (EFR). However, the surgical approaches are invasive with a longer hospital stay and greater cost, while the endoscopic approaches were limited by technical difficulty, incomplete resections and risk of perforation.
Recently, the technique of peroral endoscopic myotomy (POEM) for esophageal achalasia was introduced, a procedure in which a submucosal tunnel is created to expose and dissect the circular muscle of the esophagus. Inspired by the POEM approach, we have successfully used a similar method, endoscopic submucosal tunnel dissection (ESTD), to resect SMTs in upper gastrointestinal.
However, the long-term efficacy and safety of ESTD were not determined, and there was no prospective study compared the ESTD with other conventional approaches. Therefore, we plan to conduct this prospective randomized controlled trial, aim to determine the efficacy and safety of ESTD, compared with the pneumatic dilation, in the treatment of upper gastrointestinal SMTs originating from the muscularis propria layer .
- Conditions
- Upper Gastrointestinal Submucosal Tumors (SMTs), Gastrointestinal Stromal Tumors (GISTs), Leiomyoma
- Being tested
- ESTD, VATS
- Keywords
- upper gastrointestinal submucosal tumors, SMTs, Gastrointestinal stromal tumors, GISTs, Leiomyoma, Endoscopic submucosal tunnel dissection, ESTD, Submucosal tunneling endoscopic resection, STER, Submucosal endoscopic tumor resection, SET
- Medical subject headings
- Gastrointestinal Stromal Tumors, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTDProcedure or surgery
Also called Endoscopic submucosal tunnel dissection (ESTD), Submucosal tunneling endoscopic resection (STER), Submucosal endoscopic tumor resection (SET)
- A 2-cm longitudinal mucosal incision was made, approximately 5cm proximal to the submucosal tumor (SMTs).
- Submucosal dissection was done, creating a submucosal tunnel until the tumor was visible.
- Dissection was done along the margin of the tumor.
- After the tumor had been removed, the potential bleeding area in the tunnel was coagulated.
- Endoclips were used to close the entry of the submucosal tunnel. (Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235)
VATSProcedure or surgery
Also called Video-assisted thoracoscopic surgery, Video-thoracoscopic enucleation
- General anesthesia with double lumen intubation.
- Three to four cameras or working ports are placed over the chest wall.
- After the lesion is visualized by thoracoscopy, the mediastinal pleura over the tumor is incised longitudinally by an endoscopic hook electrocauterizer.
- The mass is exposed after the overlying muscle is split longitudinally.
- The retracting suture is placed over the mass and then meticulously dissect the plane between the mass and the submucosal layer. The integrity of the mucosa must be checked.
- The muscle layer is re-approximated and a chest tube is place through one of the ports. (Luh et al. World Journal of Surgical Oncology 2012, 10:52)
| Study group | Role | What they receive |
|---|---|---|
| ESTD | Experimental | Endoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs) Receives: Procedure: ESTD |
| VATS | Active comparator | Video-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs) Receives: Procedure: VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
En bloc resection
The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
Measured: During the operation
Secondary outcomes (5)
Curative resection
The curative resection was defined as the resected specimen with vertical and lateral margins free of neoplasia in pathological diagnosis.
Measured: From date of randomization until the date of pathological diagnosis, an expected average of 7 days
Procedure related complication
Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak, etc.
Measured: From date of operation until the occurrence of the procedure related complication, which most occur within 7 days after operation, assessed up to 2 years
Short-term morbidity
Any cause death
Measured: From date of randomization until the date of death from any cause, assessed up to 3 months
Local recurrence
Local recurrence was defined as endoscopic or histological diagnosis of cancer at the resected site in follow-up
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
Quality of life
Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life
Measured: From date of randomization until the follow-up ended, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Submucosal Tumors (SMTs)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Gong, M.D., Principal investigator, Department of Gastroenterology, Nanfang Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768104
- Sponsor's protocol ID
- NFEK-201211-K1
- Other IDs
- 201120
- Status last verified
- Dec 2011
- First submitted
- 5 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gong W, Xiong Y, Zhi F, Liu S, Wang A, Jiang B. Preliminary experience of endoscopic submucosal tunnel dissection for upper gastrointestinal submucosal tumors. Endoscopy. 2012 Mar;44(3):231-5. doi: 10.1055/s-0031-1291720. Epub 2012 Feb 21.
PubMed 22354823Zhao Y, Cai K, Liu D, Wu H, Xiong G, Wang H, Huang Z, Cai R, Wu X. [Video-assisted thoracoscopic removal of esophageal leiomyomas with intraoperative tumor location by endoscopy]. Nan Fang Yi Ke Da Xue Xue Bao. 2012 Apr;32(4):586-8. Chinese.
PubMed 22543150
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Tunnel Dissection Versus Video-assisted Thoracoscopic Surgery for Upper Gastrointestinal Submucosal Tumors: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01768104
- Acronym / sponsor ID
- NFEK-201211-K1
- Conditions
- Upper Gastrointestinal Submucosal Tumors (SMTs), Gastrointestinal Stromal Tumors (GISTs), Leiomyoma
- Keywords
- upper gastrointestinal submucosal tumors, SMTs, Gastrointestinal stromal tumors, GISTs, Leiomyoma, Endoscopic submucosal tunnel dissection, ESTD, Submucosal tunneling endoscopic resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Jan 2013 (estimated)
- 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 purpose of this study is to determine the efficacy and safety of endoscopic submucosal tunnel dissection (ESTD) compared with video-assisted thoracoscopic surgery (VATS) in the treatment of upper gastrointestinal submucosal tumors.
Detailed description
Most upper gastrointestinal submucosal tumors (SMTs), especially the gastrointestinal stromal tumors (GISTs) and leiomyoma, are regarded as benign if they are less than 3cm in size. Thus, it has been suggested that patients should receive periodic endoscopic follow-up in case of gradual changes in size; however this can be stressful and troublesome for patients. Nevertheless, some of these tumors do have a malignant potential, and management by periodic endoscopic surveillance may lead to delayed diagnosis of malignancy. Therefore, it is necessary to remove the SMTs.
To date, several approaches have been used for the treatment of upper gastrointestinal SMTs, including open, thoracoscopic and laparoscopic surgery, and endoscopic approaches such as band ligation, endoscopic submucosal dissection (ESD), and endoscopic full-thickness resection (EFR). However, the surgical approaches are invasive with a longer hospital stay and greater cost, while the endoscopic approaches were limited by technical difficulty, incomplete resections and risk of perforation.
Recently, the technique of peroral endoscopic myotomy (POEM) for esophageal achalasia was introduced, a procedure in which a submucosal tunnel is created to expose and dissect the circular muscle of the esophagus. Inspired by the POEM approach, we have successfully used a similar method, endoscopic submucosal tunnel dissection (ESTD), to resect SMTs in upper gastrointestinal.
However, the long-term efficacy and safety of ESTD were not determined, and there was no prospective study compared the ESTD with other conventional approaches. Therefore, we plan to conduct this prospective randomized controlled trial, aim to determine the efficacy and safety of ESTD, compared with the pneumatic dilation, in the treatment of upper gastrointestinal SMTs originating from the muscularis propria layer .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTD | Experimental | Procedure: ESTDEndoscopic submucosal tunnel dissection (ESTD) for patients with upper gastrointestinal submucosal tumors (SMTs) |
| VATS | Active comparator | Procedure: VATSVideo-assisted thoracoscopic surgery (VATS) for patients with upper gastrointestinal submucosal tumors (SMTs) |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18 and 75 years of age
- Patient with upper gastrointestinal submucosal tumor
- Signed informed consent
Key exclusion criteria (6 listed)
- Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
- Endoscopic ultrasound (EUS) or CT signs of metastasis
- Mega-oesophagus (greater than 7 cm) or Oesophageal diverticula in the distal oesophagus
- Previous oesophageal or gastric surgery
- Pregnancy or lactation women, or ready to pregnant women
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 |
|---|---|---|
| ESTDAlso: Endoscopic submucosal tunnel dissection (ESTD), Submucosal tunneling endoscopic resection (STER), Submucosal endoscopic tumor resection (SET)1. A 2-cm longitudinal mucosal incision was made, approximately 5cm proximal to the submucosal tumor (SMTs). 2. Submucosal dissection was done, creating a submucosal tunnel until the tumor was visible. 3. Dissection was done along the margin of the tumor. 4. After the tumor had been removed, the potential bleeding area in the tunnel was coagulated. 5. Endoclips were used to close the entry of the submucosal tunnel. (Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235) | Procedure or surgery | ESTD |
| VATSAlso: Video-assisted thoracoscopic surgery, Video-thoracoscopic enucleation1. General anesthesia with double lumen intubation. 2. Three to four cameras or working ports are placed over the chest wall. 3. After the lesion is visualized by thoracoscopy, the mediastinal pleura over the tumor is incised longitudinally by an endoscopic hook electrocauterizer. 4. The mass is exposed after the overlying muscle is split longitudinally. 5. The retracting suture is placed over the mass and then meticulously dissect the plane between the mass and the submucosal layer. The integrity of the mucosa must be checked. 6. The muscle layer is re-approximated and a chest tube is place through one of the ports. (Luh et al. World Journal of Surgical Oncology 2012, 10:52) | Procedure or surgery | VATS |
Primary outcome
En bloc resection
Time frame: During the operation
The En bloc resection was defined as a one-piece resection of the entire lesion without fragmentation
5 secondary outcomes
Curative resection
Time frame: From date of randomization until the date of pathological diagnosis, an expected average of 7 days
Procedure related complication
Time frame: From date of operation until the occurrence of the procedure related complication, which most occur within 7 days after operation, assessed up to 2 years
Short-term morbidity
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 months
Local recurrence
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Quality of life
Time frame: From date of randomization until the follow-up ended, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Background: PubMed 22354823Gong W, Xiong Y, Zhi F, Liu S, Wang A, Jiang B. Preliminary experience of endoscopic submucosal tunnel dissection for upper gastrointestinal submucosal tumors. Endoscopy. 2012 Mar;44(3):231-5. doi: 10.1055/s-0031-1291720. Epub 2012 Feb 21.
- Background: PubMed 22543150Zhao Y, Cai K, Liu D, Wu H, Xiong G, Wang H, Huang Z, Cai R, Wu X. [Video-assisted thoracoscopic removal of esophageal leiomyomas with intraoperative tumor location by endoscopy]. Nan Fang Yi Ke Da Xue Xue Bao. 2012 Apr;32(4):586-8. Chinese.
- Homepage of Nanfang Hospital of Southern Medical UniversityLink provided by the sponsor.
- Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical UniversityLink provided by the sponsor.
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.
Wei Gong, M.D. principal investigator
Department of Gastroenterology, Nanfang Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTD and VATS in people with Upper Gastrointestinal Submucosal Tumors (SMTs) and Gastrointestinal Stromal Tumors (GISTs), run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jan 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gong, M.D. (+86 15820290385, gwei203@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En bloc resection (time frame: During the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01768104, which also lists 2 linked publications.
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 15 Jan 2013.