The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection

NCT06483880 | Recruiting

• 1 other identifier: FMASU MS187/2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to study the role of adjuvant Albendazole after pulmonary hydatid cyst resection versus placebo in reducing recurrence with a short- term follow-up of six months.

Conditions

Pulmonary Hydatid Cyst

Outcome Measures

Primary Outcomes (1)

• Recurrence of pulmonary hydatid disease

  Recurrence of pulmonary hydatid disease in six months in both groups, assessed by: 1. Chest X-ray radiography after the 2 weeks. 2. CT chest in six months and after one year or symptoms requiring CT chest at any timing.

  six months

Secondary Outcomes (4)

• Liver function tests (AST and ALT) between both groups.

  Six months

• Length of hospital stay between both groups.

  Six months

• In hospital mortality between both groups.

  Six months

• Financial cost between both groups.

  Six months

Study Arms (2)

Albendazole arm

ACTIVE COMPARATOR

The administration of albendazole therapy is recommended at a dosage of 15 mg/kg/day, given in two equally split doses per day. This is within two 15-day cycles following surgery.

Drug: Albendazole

Placebo arm

PLACEBO COMPARATOR

Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery.

Drug: Placebo

Interventions

Albendazole DRUG

Patients will receive albendazole therapy at the recommended dosage.

Albendazole arm

Placebo DRUG

Patients will receive the placebo, which will be starch tablets in the same dosage of albendazole.

Placebo arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
• Patients achieving complete resection of pulmonary hydatid disease.
• Patients with no extra pulmonary hydatid disease.
• Patients who have received preoperative albendazole.

You may not qualify if:

• Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
• Patients with incomplete resection of pulmonary hydatid disease.
• Patients with pulmonary hydatid disease not amenable for resection.
• Patients with hypersensitivity to Albendazole.
• Patients with liver dysfunction.
• Patients refusing to be enrolled in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Al Abbasiya, Egypt

RECRUITING

Related Publications (7)

• Arif SH, Shams-Ul-Bari, Wani NA, Zargar SA, Wani MA, Tabassum R, Hussain Z, Baba AA, Lone RA. Albendazole as an adjuvant to the standard surgical management of hydatid cyst liver. Int J Surg. 2008 Dec;6(6):448-51. doi: 10.1016/j.ijsu.2008.08.003. Epub 2008 Aug 16.

  PMID: 18819855 BACKGROUND

• Aydin Y, Ulas AB, Ince I, Kalin A, Can FK, Gundogdu B, Kasali K, Kerget B, Ogul Y, Eroglu A. Evaluation of albendazole efficiency and complications in patients with pulmonary hydatid cyst. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):245-249. doi: 10.1093/icvts/ivab259.

  PMID: 34587626 BACKGROUND

• Dehkordi AB, Sanei B, Yousefi M, Sharafi SM, Safarnezhad F, Jafari R, Darani HY. Albendazole and Treatment of Hydatid Cyst: Review of the Literature. Infect Disord Drug Targets. 2019;19(2):101-104. doi: 10.2174/1871526518666180629134511.

  PMID: 29956639 BACKGROUND

• Fattahi Masoom SH, Lari SM, Fattahi AS, Ahmadnia N, Rajabi M, NaderiKalat M. Albendazole therapy in human lung and liver hydatid cysts: A 13-year experience. Clin Respir J. 2018 Mar;12(3):1076-1083. doi: 10.1111/crj.12630. Epub 2017 Apr 20.

  PMID: 28319358 BACKGROUND

• Rawat S, Kumar R, Raja J, Singh RS, Thingnam SKS. Pulmonary hydatid cyst: Review of literature. J Family Med Prim Care. 2019 Sep 30;8(9):2774-2778. doi: 10.4103/jfmpc.jfmpc_624_19. eCollection 2019 Sep.

  PMID: 31681642 BACKGROUND

• Sarkar M, Pathania R, Jhobta A, Thakur BR, Chopra R. Cystic pulmonary hydatidosis. Lung India. 2016 Mar-Apr;33(2):179-91. doi: 10.4103/0970-2113.177449.

  PMID: 27051107 BACKGROUND

• Teggi A, Lastilla MG, De Rosa F. Therapy of human hydatid disease with mebendazole and albendazole. Antimicrob Agents Chemother. 1993 Aug;37(8):1679-84. doi: 10.1128/AAC.37.8.1679.

  PMID: 8215283 BACKGROUND

MeSH Terms

Conditions

Echinococcosis, Pulmonary

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Echinococcosis; Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Lung Diseases, Parasitic; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 3, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)