Esophageal Anastomotic LeakAPIL_2013NCT02432794
Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy
A study testing delay phenomenon by arteriographic approach in people with Esophageal Anastomotic Leak, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Anastomotic Leak
- What is being tested?
- delay phenomenon by arteriographic approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer
- 18 or above years old
- Acceptance and signing the full informed consent
Who cannot join
- Absence of pancreatitis
- Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)
- refuse to collaborate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.
This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.
Read the detailed description
Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports).
The most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question.
For this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage.
We decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients.
- Conditions
- Esophageal Anastomotic Leak
- Being tested
- delay phenomenon by arteriographic approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delay phenomenon by arteriographic approachProcedure or surgery
we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography
| Study group | Role | What they receive |
|---|---|---|
| delay phenomenon by arteriography | Experimental | intervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.
An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well. Receives: Procedure: delay phenomenon by arteriographic approach |
| control group | No intervention | Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty.
When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions:
Thoracic drain output of oesophagogastric content with amylase > 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)
Measured: 7 days
Secondary outcomes (6)
plasty ischemia
investigators will consider plasty ischemia when one or more of the following criteria is present:
- endoscopic evidence of gastric mucosa ischemia
- evidence of low captation of the plasty in a thoracoabdominal CT with endovenous contrast that requires a reintervention.
- intraoperative mortality (during hospitalization and/or 30 days after surgery).
Measured: 7 days
hospital stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Measured: 90 days
major and minor morbidity
investigators will evaluate morbidity according to Clavien-Dindo classification
Measured: 90 days
postoperative mortality
Measured: during hospitalization and/or 30 days after surgery
post-embolization morbidity
investigators will consider post-embolization morbidity the following situations:
- abdominal pain with EVA>3 (evaluated by EVA classification )
- pancreatitis diagnosed by abdominal pain and amylase > 5 uKat/L or by CT.
- abscess, pseudocyst diagnosed by CT or during oesophageal surgery
- spleen ischemia diagnosed by CT or abdominal ultrasound and needs some treatment
- liver ischemia diagnosed by Ct or abdominal ultrasound
- bleeding or artery dissection diagnosed during the embolization and needs some treatment
- arterial pseudoaneurism diagnosed during the embolization or by CT
Measured: 30 days
anastomotic stricture
investigators will consider anastomotic stricture when they observe a reduction of anastomotic diameter by oral contrast Rx and needs some treatment (endoscopic dilation or reintervention)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Esophageal Anastomotic LeakStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandre Farran Teixidor, Hospital Universitari de Bellvitge
- Investigators
- Leandre F Teixidor, Ph D, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432794
- Sponsor's protocol ID
- APIL_2013
- Acronym
- APIL_2013
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez-Gonzalez JJ, Sanz-Alvarez L, Marques-Alvarez L, Navarrete-Guijosa F, Martinez-Rodriguez E. [Complications of surgical resection of esophageal cancer]. Cir Esp. 2006 Dec;80(6):349-60. doi: 10.1016/s0009-739x(06)70987-3. Spanish.
PubMed 17192218Schroder W, Beckurts KT, Stahler D, Stutzer H, Fischer JH, Holscher AH. Microcirculatory changes associated with gastric tube formation in the pig. Eur Surg Res. 2002 Nov-Dec;34(6):411-7. doi: 10.1159/000065709.
PubMed 12403940Farran Teixidor L, Llop Talaveron J, Galan Guzman M, Aranda Danso H, Miro Martin M, Bettonica Larranaga C, Estremiana Garcia F, Biondo S. [Surgical outcomes of esophageal cancer resection since the development of an Oesophagogastric Tumour Board]. Cir Esp. 2013 Oct;91(8):517-23. doi: 10.1016/j.ciresp.2012.12.005. Epub 2013 Apr 11. Spanish.
PubMed 23583091Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.
PubMed 1548890Griffin SM, Shaw IH, Dresner SM. Early complications after Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy: risk factors and management. J Am Coll Surg. 2002 Mar;194(3):285-97. doi: 10.1016/s1072-7515(01)01177-2.
PubMed 11893132Schroder W, Holscher AH, Bludau M, Vallbohmer D, Bollschweiler E, Gutschow C. Ivor-Lewis esophagectomy with and without laparoscopic conditioning of the gastric conduit. World J Surg. 2010 Apr;34(4):738-43. doi: 10.1007/s00268-010-0403-x.
PubMed 20098986Metzger R, Bollschweiler E, Vallbohmer D, Maish M, DeMeester TR, Holscher AH. High volume centers for esophagectomy: what is the number needed to achieve low postoperative mortality? Dis Esophagus. 2004;17(4):310-4. doi: 10.1111/j.1442-2050.2004.00431.x.
PubMed 15569369Liebermann-Meffert DM, Meier R, Siewert JR. Vascular anatomy of the gastric tube used for esophageal reconstruction. Ann Thorac Surg. 1992 Dec;54(6):1110-5. doi: 10.1016/0003-4975(92)90077-h.
PubMed 1449294Boyle NH, Pearce A, Hunter D, Owen WJ, Mason RC. Scanning laser Doppler flowmetry and intraluminal recirculating gas tonometry in the assessment of gastric and jejunal perfusion during oesophageal resection. Br J Surg. 1998 Oct;85(10):1407-11. doi: 10.1046/j.1365-2168.1998.00943.x.
PubMed 9782026Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.
PubMed 7790342Yuan Y, Duranceau A, Ferraro P, Martin J, Liberman M. Vascular conditioning of the stomach before esophageal reconstruction by gastric interposition. Dis Esophagus. 2012 Nov-Dec;25(8):740-9. doi: 10.1111/j.1442-2050.2011.01311.x. Epub 2012 Jan 31.
PubMed 22292613Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.
PubMed 9881938Isomura T, Itoh S, Endo T, Akiyama S, Maruyama K, Ishiguchi T, Ishigaki T, Takagi H. Efficacy of gastric blood supply redistribution by transarterial embolization: preoperative procedure to prevent postoperative anastomotic leaks following esophagoplasty for esophageal carcinoma. Cardiovasc Intervent Radiol. 1999 Mar-Apr;22(2):119-23. doi: 10.1007/s002709900346.
PubMed 10094991Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x.
PubMed 18477261Farran L, Miro M, Alba E, Bettonica C, Aranda H, Galan M, Rafecas A. Preoperative gastric conditioning in cervical gastroplasty. Dis Esophagus. 2011 May;24(4):205-10. doi: 10.1111/j.1442-2050.2010.01115.x. Epub 2010 Oct 11.
PubMed 21040153
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.
- ClinicalTrials.gov ID
- NCT02432794
- Acronym / sponsor ID
- APIL_2013 / APIL_2013
- Conditions
- Esophageal Anastomotic Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 May 2015 (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.
This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.
Detailed description
Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate in specialized centers (up to 60% in some groups). One of the most important postoperative complications is the oesophagogastric anastomotic leakage which leads to high morbidity (mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60% depending on the reports).
The most important cause of anastomotic leakage is the stomach's extreme sensitivity to ischemic injury. There are several experimental studies that have demonstrated that the delay phenomenon before the esophageal resection surgery aims to improve blood perfusion after a period of time. Few studies, only case-reports, describe a decrease in the incidence of intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled trials to answer this question.
For this reason the investigators propose to perform a prospective randomized controlled trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure before esophageal resection surgery, and the other one will be operated on directly, to demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric leakage.
We decided to conduct this trial as a pilot study due to the fact that the number of patients needed to achieve statistical significance was to high and would have taken almost 10 years. We established a recruitment period of 3 years, in wich we intend to include 60 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delay phenomenon by arteriography | Experimental | Procedure: delay phenomenon by arteriographic approachintervention: delay phenomenon by arteriography. Patients who will be subjected a delay phenomenon by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery. An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. A 4-5 Fr Simmons or Cobra catheter is used for the catheterization and embolization of the left gastric artery, and 0.035-inch platinum coils are proximally placed from the main trunk in the splenic artery. When accessory left gastric arteries are present, they are catheterized and embolized as well. The right gastric artery catheterization is realized by a 4-5 Fr catheter and coils or microcoils are proximally placed in the artery as well. |
| control group | No intervention | –Patients who will be operated directly without gastric ischemic conditioning. The investigators don't performed any arteriography before the esophageal surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients requiring a subtotal esophagectomy with en-bloc resection and an intrathoracic esophagogastrostomy for esophageal cancer
- 18 or above years old
- Acceptance and signing the full informed consent
Key exclusion criteria (3 listed)
- Absence of pancreatitis
- Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament,etc,..)
- refuse to collaborate in the study
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 |
|---|---|---|
| delay phenomenon by arteriographic approachwe improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography | Procedure or surgery | delay phenomenon by arteriography |
Primary outcome
Anastomotic leakage
Time frame: 7 days
investigators will consider anastomotic dehiscence the presence of one or more of the following conditions: radiologic confirmation by water-soluble contrast study (gastrografin administered orally) or thoracoabdominal Tc with oral contrast of dehiscence of oesophagogastric anastomosis or the stapler end of the gastroplasty. When the clinical conditions of patient don't allow a Rx control investigators will consider an anastomotic leakage in these conditions: Thoracic drain output of oesophagogastric content with amylase > 40 ukAT/L, confirmation of anastomotic dehiscence by the surgeon during a reintervention, endoscopic confirmation of anastomotic leakage of the stapled end of the plasty and methylene blue output after oral administration (100 ml of water with 10ml of methylene blue)
6 secondary outcomes
plasty ischemia
Time frame: 7 days
hospital stay
Time frame: 90 days
major and minor morbidity
Time frame: 90 days
postoperative mortality
Time frame: during hospitalization and/or 30 days after surgery
post-embolization morbidity
Time frame: 30 days
anastomotic stricture
Time frame: 6 months
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 20 Aug 2019.
- Results publication: PubMed 17192218Gonzalez-Gonzalez JJ, Sanz-Alvarez L, Marques-Alvarez L, Navarrete-Guijosa F, Martinez-Rodriguez E. [Complications of surgical resection of esophageal cancer]. Cir Esp. 2006 Dec;80(6):349-60. doi: 10.1016/s0009-739x(06)70987-3. Spanish.
- Results publication: PubMed 12403940Schroder W, Beckurts KT, Stahler D, Stutzer H, Fischer JH, Holscher AH. Microcirculatory changes associated with gastric tube formation in the pig. Eur Surg Res. 2002 Nov-Dec;34(6):411-7. doi: 10.1159/000065709.
- Results publication: PubMed 23583091Farran Teixidor L, Llop Talaveron J, Galan Guzman M, Aranda Danso H, Miro Martin M, Bettonica Larranaga C, Estremiana Garcia F, Biondo S. [Surgical outcomes of esophageal cancer resection since the development of an Oesophagogastric Tumour Board]. Cir Esp. 2013 Oct;91(8):517-23. doi: 10.1016/j.ciresp.2012.12.005. Epub 2013 Apr 11. Spanish.
- Results publication: PubMed 1548890Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. doi: 10.1002/jso.2930490307.
- Results publication: PubMed 11893132Griffin SM, Shaw IH, Dresner SM. Early complications after Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy: risk factors and management. J Am Coll Surg. 2002 Mar;194(3):285-97. doi: 10.1016/s1072-7515(01)01177-2.
- Results publication: PubMed 20098986Schroder W, Holscher AH, Bludau M, Vallbohmer D, Bollschweiler E, Gutschow C. Ivor-Lewis esophagectomy with and without laparoscopic conditioning of the gastric conduit. World J Surg. 2010 Apr;34(4):738-43. doi: 10.1007/s00268-010-0403-x.
- Results publication: PubMed 15569369Metzger R, Bollschweiler E, Vallbohmer D, Maish M, DeMeester TR, Holscher AH. High volume centers for esophagectomy: what is the number needed to achieve low postoperative mortality? Dis Esophagus. 2004;17(4):310-4. doi: 10.1111/j.1442-2050.2004.00431.x.
- Results publication: PubMed 1449294Liebermann-Meffert DM, Meier R, Siewert JR. Vascular anatomy of the gastric tube used for esophageal reconstruction. Ann Thorac Surg. 1992 Dec;54(6):1110-5. doi: 10.1016/0003-4975(92)90077-h.
- Results publication: PubMed 9782026Boyle NH, Pearce A, Hunter D, Owen WJ, Mason RC. Scanning laser Doppler flowmetry and intraluminal recirculating gas tonometry in the assessment of gastric and jejunal perfusion during oesophageal resection. Br J Surg. 1998 Oct;85(10):1407-11. doi: 10.1046/j.1365-2168.1998.00943.x.
- Results publication: PubMed 7790342Urschel JD. Ischemic conditioning of the rat stomach: implications for esophageal replacement with stomach. J Cardiovasc Surg (Torino). 1995 Apr;36(2):191-3.
- Results publication: PubMed 22292613Yuan Y, Duranceau A, Ferraro P, Martin J, Liberman M. Vascular conditioning of the stomach before esophageal reconstruction by gastric interposition. Dis Esophagus. 2012 Nov-Dec;25(8):740-9. doi: 10.1111/j.1442-2050.2011.01311.x. Epub 2012 Jan 31.
- Results publication: PubMed 9881938Akiyama S, Kodera Y, Sekiguchi H, Kasai Y, Kondo K, Ito K, Takagi H. Preoperative embolization therapy for esophageal operation. J Surg Oncol. 1998 Dec;69(4):219-23. doi: 10.1002/(sici)1096-9098(199812)69:43.0.co;2-7.
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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.
Leandre F Teixidor, Ph D, MD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delay phenomenon by arteriographic approach in people with Esophageal Anastomotic Leak, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 3 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 20 Aug 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 Spain. 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?
Anastomotic leakage (time frame: 7 days). 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 NCT02432794, which also lists 16 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 20 Aug 2019.