CirrhosisSVELNCT04244487
Laparoscopic Splenectomy and Azygoportal Disconnection With Intraoperative Endoscopic Variceal Ligation
A study testing laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation in people with Cirrhosis and Hypertension, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Hypertension, Splenectomy
- What is being tested?
- laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2020to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism
- esophageal/gastroesophageal variceal bleeding
- No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
- Informed consent to participate in the study
Who cannot join
- Hepatocellular carcinoma or any other malignancy,
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Child - Pugh C
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
Show all 10Show fewer
- Pregnancy
- Uncontrolled Hypertension
- Age>75 yrs
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu, 225001
About this study
Official title: Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection With Versus Without Intraoperative Endoscopic Variceal Ligation
This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.
Read the detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (SVEL)) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 6, and 12 after operation, endoscopic intervention will be done for all patients. Endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. Postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.
- Conditions
- Cirrhosis, Hypertension, Splenectomy, Laparoscopy
- Being tested
- laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation
- Keywords
- Vagus nerve, Esophageal variceal re-bleeding, Cirrhosis, Hypertension, laparoscopy
- Medical subject headings
- Fibrosis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligationProcedure or surgery
The modified procedure was implemented in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, divide the left lateral surface of the distal esophagus; (3) divide the posterior surface of the distal esophagus; (4) divide the anterior surface of the distal esophagus; (5) divide the lesser omental sac via the bottom right crural diaphragm; (6) transect en bloc the left gastric artery and vein and posterior gastric veins using a linear laparoscopic vascular stapler; (7) find the right crural diaphragm by dividing a small portion of the hepatogastric ligament at the left lateral esophagogastric junction; and (8) via the surface of the right crural diaphragm, divide the right lateral surface of the distal esophagus.
After the procedure of laparoscopic azygoportal disconnection, intraoperative endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm.
| Study group | Role | What they receive |
|---|---|---|
| intraoperative endoscopic variceal ligation group | Experimental | intraoperative endoscopic variceal ligation group Every patient of vagus nerve-preserving group will receive the synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation procedure Receives: Procedure: laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation |
| Non-intraoperative endoscopic variceal ligation group | No intervention | Every patient of conventional group will receive single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal variceal re-bleeding
Proportions of patients who will suffer from esophageal variceal re-bleeding
Measured: 1 year
Secondary outcomes (2)
Death due to re-bleeding
Proportions of patients who will suffer from death due to re-bleeding
Measured: 1 year
Overall survival
Overall survival in both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start3 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Luo-Jing Zhou, MD, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244487
- Sponsor's protocol ID
- YZUC-004
- Acronym
- SVEL
- Status last verified
- Dec 2023
- First submitted
- 18 Jan 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai DS, Jin SJ, Xiang XX, Qian JJ, Zhang C, Zhou BH, Gao TM, Jiang GQ. Vagus Nerve-Preserving Laparoscopic Splenectomy and Azygoportal Disconnection with Versus Without Intraoperative Endoscopic Variceal Ligation: a Randomized Clinical Trial. J Gastrointest Surg. 2022 Sep;26(9):1838-1845. doi: 10.1007/s11605-022-05374-1. Epub 2022 Jun 8.
PubMed 35676457
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve-preserving Laparoscopic Splenectomy and Azygoportal Disconnection With Versus Without Intraoperative Endoscopic Variceal Ligation
- ClinicalTrials.gov ID
- NCT04244487
- Acronym / sponsor ID
- SVEL / YZUC-004
- Conditions
- Cirrhosis, Hypertension, Splenectomy, Laparoscopy
- Keywords
- Vagus nerve, Esophageal variceal re-bleeding, Cirrhosis, Hypertension, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jan 2020 (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.
This study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL) is effective and safe, and to determine whether SVEL can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.
Detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. The baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (SVEL)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (SVEL)) group. From postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (Bayer, Leverkusen, Germany) once daily for 1 year, low-molecular-weight heparin (CS Bio, Hebei, China) subcutaneously (4.100 IU/day) for 5 days, and 25 mg of oral dipyridamole (Henan Furen, Henan, China) thrice daily for 3 months. At months 3, 6, and 12 after operation, endoscopic intervention will be done for all patients. Endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. Postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraoperative endoscopic variceal ligation group | Experimental | Procedure: laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligationintraoperative endoscopic variceal ligation group Every patient of vagus nerve-preserving group will receive the synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation procedure |
| Non-intraoperative endoscopic variceal ligation group | No intervention | –Every patient of conventional group will receive single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism
- esophageal/gastroesophageal variceal bleeding
- No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT
- Informed consent to participate in the study
Key exclusion criteria (10 listed)
- Hepatocellular carcinoma or any other malignancy,
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Child - Pugh C
- Recent peptic ulcer 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 |
|---|---|---|
| laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligationThe modified procedure was implemented in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, divide the left lateral surface of the distal esophagus; (3) divide the posterior surface of the distal esophagus; (4) divide the anterior surface of the distal esophagus; (5) divide the lesser omental sac via the bottom right crural diaphragm; (6) transect en bloc the left gastric artery and vein and posterior gastric veins using a linear laparoscopic vascular stapler; (7) find the right crural diaphragm by dividing a small portion of the hepatogastric ligament at the left lateral esophagogastric junction; and (8) via the surface of the right crural diaphragm, divide the right lateral surface of the distal esophagus. After the procedure of laparoscopic azygoportal disconnection, intraoperative endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm. | Procedure or surgery | intraoperative endoscopic variceal ligation group |
Primary outcome
Esophageal variceal re-bleeding
Time frame: 1 year
Proportions of patients who will suffer from esophageal variceal re-bleeding
2 secondary outcomes
Death due to re-bleeding
Time frame: 1 year
Overall survival
Time frame: 1 year
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 26 Dec 2023.
- Derived from this study: PubMed 35676457Bai DS, Jin SJ, Xiang XX, Qian JJ, Zhang C, Zhou BH, Gao TM, Jiang GQ. Vagus Nerve-Preserving Laparoscopic Splenectomy and Azygoportal Disconnection with Versus Without Intraoperative Endoscopic Variceal Ligation: a Randomized Clinical Trial. J Gastrointest Surg. 2022 Sep;26(9):1838-1845. doi: 10.1007/s11605-022-05374-1. Epub 2022 Jun 8.
- 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.
Luo-Jing Zhou, MD study chair
Clinical Medical College, Yangzhou 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 laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation in people with Cirrhosis and Hypertension, run by Northern Jiangsu People's Hospital 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 5 inclusion and 10 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 26 Dec 2023. 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?
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?
Esophageal variceal re-bleeding (time frame: 1 year). 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 NCT04244487, which also lists 1 linked publication.
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 26 Dec 2023.