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AzTrials

Acute Calculous CholecystitisPhase 3NCT07378410

Role of Intra-Operative Aspiration in Distended GB in LC

A Phase 3 study testing Laparoscopic needle in people with Acute Calculous Cholecystitis and Gallbladder Empyema, run by Aswan University at 1 site in Egypt.

Completed

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

Official record
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Trial summary

Laparoscopic cholecystectomy (LC) is a standard procedure for gallstones and the standard surgical approach for acute calcular cholecystitis, superseding open cholecystectomy for gallbladder (GB) pathologies. Read more about this study

Who is it for?
Any age
What is being tested?
Laparoscopic needle
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
1 Jul 2023to 1 Jan 2026
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient with calcular cholecystitis, GB mucocele or GB empyema
  • Distended gallbladder: shiny, over distended, long, difficult to grasp and manipulate gallbladder.
  • Acute or chronic calcular cholecystitis

Who cannot join

  • Obstructive jaundice
  • Non distended gallbladder
  • Previous upper abdomen operations
  • Pregnant

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Aswan University

    Aswān

Other trials in Egypt

About this study

Official title: Outcomes of Intra-Operative Aspiration Vs Non-Aspiration for Distended Gallbladder in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (LC) is a standard procedure for gallstones and the standard surgical approach for acute calcular cholecystitis, superseding open cholecystectomy for gallbladder (GB) pathologies. Despite this progress, mortality rates in high-risk cohorts remain substantial, ranging between 3.7% and 41.0%. Moreover, the recommended modality for mucocele which is defined as distension and marked dilatation of the GB associated with dysfunction is LC.

The routine aspiration showed significant less percentage of GB perforation during surgery with similarity for other factors . However, routine aspiration of the GB during uncomplicated LC is considered an unnecessary intervention and therefore not recommended as a routine practice.

Read more

Accidental GB perforation occurs in about 20% of laparoscopic cholecystectomies, and bile contamination in the abdominal cavity can cause SSI and lead to the formation of a residual abscess or wound infection.

Grasping a thick and distended GB is one of the most common technical difficulties of laparoscopic cholecystectomy in acute cholecystitis. If the GB is distended it should be decompressed it to avoid conversion to open due to bile duct injury or perforation with spillage of bile and gallstones previously, authors had advocated conversion if iatrogenic perforation occurred.

Read the detailed description

This study was conducted on patients with symptomatic calcular cholecystitis presented to Aswan university hospital.

The following parameters were measured intraoperative difficulty.

  • Operative time
  • Incidence of biliary tree injury
  • Higher surgeon consultation
  • Conversion into open surgery All groups were followed up for 30 days period for post-operative complication clinically and by sonar.
  • Wound infection
  • Liver bed bleeding
  • Collection in the liver bed
  • Peritonitis
  • Hospital stays.
Being tested
Laparoscopic needle
Keywords
Acute Calculous Cholecystitis, Gallbladder Empyema, Gallbladder Mucocele, Distended gallbladder, Intra-operative aspiration
Medical subject headings
Cholecystitis, Acute, Cholecystitis

What participants receive

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

  • Laparoscopic needleProcedure or surgery

    During classic LC, either with preoperative or accidently intra-operative overdistended GB using a laparoscopic needle to decompress the GB and make the operation much easier

Study groups in NCT07378410
Study groupRoleWhat they receive
Aspiration groupExperimentalNot described
Receives: Procedure: Laparoscopic needle
Non-Aspiration groupNo interventionNot described

What is being measured

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

  1. Difficulty of the operation

    the difficulty will be assessed by the following Operative time, Incidence of biliary tree injury, Higher surgeon consultation and Conversion to open chole

    Measured: 30 days

Secondary outcomes (4)

  1. Liver bed bleeding

    checking post procedures and postoperative through the drain

    Measured: 30 days

  2. 30-day mortality

    follow-up the patient in the outpatient and by phone

    Measured: 30 days

  3. Hospital stays.

    total stay in the hospital

    Measured: 30 days

  4. Peritonitis

    incidence of peritonitis in the first week of the operation

    Measured: 30 days

Timeline

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

  1. First posted30 Jan 2026
  2. Study start1 Jul 2023
  3. Primary completion1 Jan 2026
  4. Study completion1 Jan 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
comparing the efficacy of intra-operative Gallbladder content aspiration in overdistended cases with completion of the operation without aspiration
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378410
Sponsor's protocol ID
Asw.Uni./978/9/24
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barrat C, Champault A, Matthyssens L, Champault G. [Iatrogenic perforation of the gallbladder during laparoscopic cholecystectomy does not influence the prognosis. Prospective study]. Ann Chir. 2004 Feb;129(1):25-9. doi: 10.1016/j.anchir.2003.11.011. French.

    PubMed 15019851

  • Calik, A., Topaloglu, S., Topcu, S., Turkyilmaz, S., Kucuktulu, U., & Piskin, B. (2007). Routine intraoperative aspiration of gallbladder during laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques, 21(9), 1578-1581. https://doi.org/10.1007/s00464-006-9159-7 Guzmán-Valdivia, G. (2008). Routine Administration of Antibiotics to Patients Suffering Accidental Gallbladder Perforation During Laparoscopic Cholecystectomy is not Necessary. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 18(6), 547-550. https://doi.org/10.1097/SLE.0b013e3181809e72 Lee, K.-T., Shan, Y.-S., Wang, S.-T., & Lin, P.-W. (2005). Verres needle decompression of distended gallbladder to facilitate laparoscopic cholecystectomy in acute cholecystitis: A prospective study. Hepato-Gastroenterology, 52(65), 1388-1392. Lisotti, A., Linguerri, R., Bacchilega, I., Cominardi, A., Marocchi, G., & Fusaroli, P. (2022). EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-Procedure outcomes and evaluation of mortality predictors. Surgical Endoscopy, 36(1), 569-578. https://doi.org/10.1007/s00464-021-08318-z Majumder, A., Altieri, M. S., & Brunt, L. M. (2020). How do I do it: Laparoscopic cholecystectomy. Annals of Laparoscopic and Endoscopic Surgery, 5, 15-15. https://doi.org/10.21037/ales.2020.02.06 Mishra, R. K. (2022, June 12). Cholecystectomy for Mucocele of Gallbladder. https://www.laparoscopyhospital.com/streamvideo/index.php?pid=536&p=28 Ponsky, J. L. (1991). Complications of laparoscopic cholecystectomy. The American Journal of Surgery, 161(3), 393-395. https://doi.org/10.1016/0002-9610(91)90605-D Shea, J. A., Berlin, J. A., Bachwich, D. R., Staroscik, R. N., Malet, P. F., McGuckin, M., Schwartz, J. S., & Escarce, J. J. (1998). Indications for and Outcomes of Cholecystectomy. Annals of Surgery, 227(3), 343-350. https://doi.org/10.1097/00000658-199803000-00005 Shirah, B. H., Shirah, H. A., & Albeladi, K. B. (2018). The value of intraoperative percutaneous aspiration of the mucocele of the gallbladder for safe laparoscopic management. Updates in Surgery, 70(4), 495-502. https://doi.org/10.1007/s13304-018-0565-x Siddiqui, M. R. S., Sajid, M. S., Nisar, A., Ali, H., Zaborszky, A., & Hasan, F. (2011). A meta-analysis of outcomes after routine aspiration of the gallbladder during cholecystectomy. International Surgery, 96(1), 21-27. https://doi.org/10.9738/1361.1 Usuba, T., Nyumura, Y., Takano, Y., Iino, T., & Hanyu, N. (2017). Clinical outcomes of laparoscopic cholecystectomy with accidental gallbladder perforation. Asian Journal of Endoscopic Surgery, 10(2), 162-165. https://doi.org/10.1111/ases.12348 Wood, S., Lewis, W., & Egan, R. (2019). Optimising Surgical Technique in Laparoscopic Cholecystectomy: A Review of Intraoperative Interventions. Journal of Gastrointestinal Surgery, 23(9), 1925-1932. https://doi.org/10.1007/s11605-019-04296-9

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laparoscopic needle in people with Acute Calculous Cholecystitis and Gallbladder Empyema, run by Aswan University at 1 site in Egypt.

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 4 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 30 Jan 2026. 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 Egypt. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Difficulty of the operation (time frame: 30 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 NCT07378410, 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 30 Jan 2026.

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