Esophageal and Gastric VaricesNCT05331768

Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy

A study testing banding ligation plus terlipressin infusion in people with Esophageal and Gastric Varices, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Esophageal and Gastric Varices
What is being tested?: banding ligation plus terlipressin infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteMexico
Study dates: 1 Jan 2021to 30 Sep 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients of 18 years and older
Both genders,
Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C)
Acute variceal bleeding were included

Who cannot join

Patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases),
Presence of sepsis,
Multi-organ failure,
The requirement of continuous ionotropic or ventilatory support,
Bleeding disorders,
Hepatocellular carcinoma or other extrahepatic malignanc.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Centro Médico Nacional de Occidente
Guadalajara, Jalisco, 44329

Other trials in Mexico

About this study

Official title: Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy for the Control of Acute Variceal Bleeding in Patients With Liver Cirrhosis at a Tertiary Center in Mexico

In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.

Read the detailed description

Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.

Conditions: Esophageal and Gastric Varices
Being tested: banding ligation plus terlipressin infusion
Keywords: Terlipressin, Liver Cirrhosis, Esophageal and Gastric Varices,, Collateral Circulations
Medical subject headings: Esophageal and Gastric Varices, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

banding ligation plus terlipressin infusionCombination product
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.

Study groups in NCT05331768
Study group	Role	What they receive
24-h group	Experimental	The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours. Receives: Combination Product: banding ligation plus terlipressin infusion
72-h group	Active comparator	The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe Receives: Combination Product: banding ligation plus terlipressin infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare the 24-h group vs 72-h group
Differences between groups at baseline were evaluated with Student's t-test test for continuous variables and proportions were compared using the Chi2 or Fisher test.
Measured: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202130 Sep 2021

First posted18 Apr 2022
Study start1 Jan 2021
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Esophageal and Gastric VaricesStudies 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
Model description: This was a randomized clinical trial. Eligible patients were randomised to receive banding ligation plus terlipressin infusion for 24 hours or banding ligation plus terlipressin infusion for 72 hours
Masking: Single blind
Who is masked: Participant
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05331768
Sponsor's protocol ID: Terlipressin proyect
Status last verified: Apr 2022
First submitted: 29 Mar 2022
Last updated: 18 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: It is expected to find a journal that is interested in our research and that is open access

Publications

Roesch-Dietlen F, Gonzalez-Santes M, Sanchez-Maza YJ, Diaz-Roesch F, Cano-Contreras AD, Amieva-Balmori M, Garcia-Zermeno KR, Salgado-Vergara L, Remes-Troche JM, Ortigoza-Gutierrez S. Influence of socioeconomic and cultural factors in the etiology of cirrhosis of the liver. Rev Gastroenterol Mex (Engl Ed). 2021 Jan-Mar;86(1):28-35. doi: 10.1016/j.rgmx.2020.01.002. Epub 2020 Apr 25. English, Spanish.
PubMed 32345507
Berardo C, Di Pasqua LG, Cagna M, Richelmi P, Vairetti M, Ferrigno A. Nonalcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis: Current Issues and Future Perspectives in Preclinical and Clinical Research. Int J Mol Sci. 2020 Dec 17;21(24):9646. doi: 10.3390/ijms21249646.
PubMed 33348908
Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.
PubMed 30697445
Bosch J, Pizcueta MP, Fernandez M, Feu F, Cirera I, Luca A, Garcia-Pagan JC. Hepatic, splanchnic and systemic haemodynamic abnormalities in portal hypertension. Baillieres Clin Gastroenterol. 1992 Sep;6(3):425-36. doi: 10.1016/0950-3528(92)90030-i.
PubMed 1421593
Kalambokis G, Tsiouris S, Tsianos EV, Baltayiannis G, Pakou B, Fotopoulos A. Effects of terlipressin and somatostatin on liver and thorax blood volumes in patients with cirrhosis. Liver Int. 2010 Oct;30(9):1371-8. doi: 10.1111/j.1478-3231.2010.02322.x.
PubMed 20738780
Kovalak M, Lake J, Mattek N, Eisen G, Lieberman D, Zaman A. Endoscopic screening for varices in cirrhotic patients: data from a national endoscopic database. Gastrointest Endosc. 2007 Jan;65(1):82-8. doi: 10.1016/j.gie.2006.08.023.
PubMed 17185084
Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
PubMed 17879356
Fortune BE, Groszmann RJ. Combination of splanchnic vasoconstrictors and endoscopic band ligation is an effective treatment strategy for acute variceal hemorrhage; but how do we get those drugs approved by the FDA? Hepatology. 2014 Sep;60(3):789-91. doi: 10.1002/hep.27080. Epub 2014 Jul 28. No abstract available.
PubMed 24700393
Bendtsen F, Krag A, Moller S. Treatment of acute variceal bleeding. Dig Liver Dis. 2008 May;40(5):328-36. doi: 10.1016/j.dld.2007.12.005. Epub 2008 Feb 1.
PubMed 18243077
Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.
PubMed 30508958
Banares R, Albillos A, Rincon D, Alonso S, Gonzalez M, Ruiz-del-Arbol L, Salcedo M, Molinero LM. Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis. Hepatology. 2002 Mar;35(3):609-15. doi: 10.1053/jhep.2002.31354.
PubMed 11870374
Krag A, Borup T, Moller S, Bendtsen F. Efficacy and safety of terlipressin in cirrhotic patients with variceal bleeding or hepatorenal syndrome. Adv Ther. 2008 Nov;25(11):1105-40. doi: 10.1007/s12325-008-0118-7.
PubMed 19018483
Dohler KD, Walker S, Mentz P, Forssmann K, Staritz M. [Vasoconstrictive Therapies for Bleeding Esophageal Varices and their Mechanisms of Action]. Z Gastroenterol. 2003 Oct;41(10):1001-16. doi: 10.1055/s-2003-42931. German.
PubMed 14562199
Salim A, Malik K, Haq IU, Butt AK, Alam A. Comparison of 12-Hour with 72-Hour Terlipressin Therapy for Bleeding Esophageal Varices. J Coll Physicians Surg Pak. 2017 Jun;27(6):334-337.
PubMed 28689520
Moller S, Hansen EF, Becker U, Brinch K, Henriksen JH, Bendtsen F. Central and systemic haemodynamic effects of terlipressin in portal hypertensive patients. Liver. 2000 Feb;20(1):51-9. doi: 10.1034/j.1600-0676.2000.020001051.x.
PubMed 10726961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
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Not yet recruitingObservational study
Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
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All Esophageal and Gastric Varices trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy for the Control of Acute Variceal Bleeding in Patients With Liver Cirrhosis at a Tertiary Center in Mexico
ClinicalTrials.gov ID: NCT05331768
Acronym / sponsor ID: Terlipressin proyect
Conditions: Esophageal and Gastric Varices
Keywords: Terlipressin, Liver Cirrhosis, Esophageal and Gastric Varices,, Collateral Circulations
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Study start: 1 Jan 2021 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 18 Apr 2022 (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.

Detailed description

Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This was a randomized clinical trial. Eligible patients were randomised to receive banding ligation plus terlipressin infusion for 24 hours or banding ligation plus terlipressin infusion for 72 hours

Arm	Type	Receives
24-h group	Experimental	Combination Product: banding ligation plus terlipressin infusionThe 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
72-h group	Active comparator	Combination Product: banding ligation plus terlipressin infusionThe 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients of 18 years and older
Both genders,
Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C)
Acute variceal bleeding were included

Key exclusion criteria (6 listed)

Patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases),
Presence of sepsis,
Multi-organ failure,
The requirement of continuous ionotropic or ventilatory support,
Bleeding disorders,

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
banding ligation plus terlipressin infusionSubjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.	Combination product	24-h group, 72-h group

Primary outcome

Compare the 24-h group vs 72-h group
Time frame: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event
Differences between groups at baseline were evaluated with Student's t-test test for continuous variables and proportions were compared using the Chi2 or Fisher test.

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 18 Apr 2022.
Background: PubMed 32345507Roesch-Dietlen F, Gonzalez-Santes M, Sanchez-Maza YJ, Diaz-Roesch F, Cano-Contreras AD, Amieva-Balmori M, Garcia-Zermeno KR, Salgado-Vergara L, Remes-Troche JM, Ortigoza-Gutierrez S. Influence of socioeconomic and cultural factors in the etiology of cirrhosis of the liver. Rev Gastroenterol Mex (Engl Ed). 2021 Jan-Mar;86(1):28-35. doi: 10.1016/j.rgmx.2020.01.002. Epub 2020 Apr 25. English, Spanish.
Background: PubMed 33348908Berardo C, Di Pasqua LG, Cagna M, Richelmi P, Vairetti M, Ferrigno A. Nonalcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis: Current Issues and Future Perspectives in Preclinical and Clinical Research. Int J Mol Sci. 2020 Dec 17;21(24):9646. doi: 10.3390/ijms21249646.
Background: PubMed 30697445Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.
Background: PubMed 1421593Bosch J, Pizcueta MP, Fernandez M, Feu F, Cirera I, Luca A, Garcia-Pagan JC. Hepatic, splanchnic and systemic haemodynamic abnormalities in portal hypertension. Baillieres Clin Gastroenterol. 1992 Sep;6(3):425-36. doi: 10.1016/0950-3528(92)90030-i.
Background: PubMed 20738780Kalambokis G, Tsiouris S, Tsianos EV, Baltayiannis G, Pakou B, Fotopoulos A. Effects of terlipressin and somatostatin on liver and thorax blood volumes in patients with cirrhosis. Liver Int. 2010 Oct;30(9):1371-8. doi: 10.1111/j.1478-3231.2010.02322.x.
Background: PubMed 17185084Kovalak M, Lake J, Mattek N, Eisen G, Lieberman D, Zaman A. Endoscopic screening for varices in cirrhotic patients: data from a national endoscopic database. Gastrointest Endosc. 2007 Jan;65(1):82-8. doi: 10.1016/j.gie.2006.08.023.
Background: PubMed 17879356Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
Background: PubMed 24700393Fortune BE, Groszmann RJ. Combination of splanchnic vasoconstrictors and endoscopic band ligation is an effective treatment strategy for acute variceal hemorrhage; but how do we get those drugs approved by the FDA? Hepatology. 2014 Sep;60(3):789-91. doi: 10.1002/hep.27080. Epub 2014 Jul 28. No abstract available.
Background: PubMed 18243077Bendtsen F, Krag A, Moller S. Treatment of acute variceal bleeding. Dig Liver Dis. 2008 May;40(5):328-36. doi: 10.1016/j.dld.2007.12.005. Epub 2008 Feb 1.
Background: PubMed 30508958Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.
Background: PubMed 11870374Banares R, Albillos A, Rincon D, Alonso S, Gonzalez M, Ruiz-del-Arbol L, Salcedo M, Molinero LM. Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis. Hepatology. 2002 Mar;35(3):609-15. doi: 10.1053/jhep.2002.31354.
Background: PubMed 19018483Krag A, Borup T, Moller S, Bendtsen F. Efficacy and safety of terlipressin in cirrhotic patients with variceal bleeding or hepatorenal syndrome. Adv Ther. 2008 Nov;25(11):1105-40. doi: 10.1007/s12325-008-0118-7.
Individual participant dataSharing planned: Undecided. It is expected to find a journal that is interested in our research and that is open access

Related trials for Esophageal and Gastric Varices

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The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
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Not yet recruitingObservational study
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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.

Alejandro González-Ojeda principal investigator

Instituto Mexicano del Seguro Social

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing banding ligation plus terlipressin infusion in people with Esophageal and Gastric Varices, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 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: finished, as of the sponsor's last update on 18 Apr 2022. 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 Mexico. 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?

Compare the 24-h group vs 72-h group (time frame: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event). 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 NCT05331768, which also lists 21 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 18 Apr 2022.