Role of Intra-Operative Aspiration in Distended GB in LC

NCT07378410 | Completed Phase 3

• 1 other identifier: Asw.Uni./978/9/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Acute Calculous Cholecystitis; Gallbladder Empyema; Gallbladder Mucocele

Keywords

Acute Calculous Cholecystitis; Gallbladder Empyema; Gallbladder Mucocele; Distended gallbladder; Intra-operative aspiration

Outcome Measures

Primary Outcomes (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

  30 days

Secondary Outcomes (4)

• Liver bed bleeding

  30 days

• 30-day mortality

  30 days

• Hospital stays.

  30 days

• Peritonitis

  30 days

Study Arms (2)

Aspiration group

EXPERIMENTAL

Procedure: Laparoscopic needle

Non-Aspiration group

NO INTERVENTION

Interventions

Laparoscopic needle PROCEDURE

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

Aspiration group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, Egypt

Location

Related Publications (2)

• Barrat, C., Champault, A., Matthyssens, L., & Champault, G. (2004). L'effraction de la vésicule lors des cholécystectomies laparoscopiques n'influence pas la morbidité. Étude prospective. Annales de Chirurgie, 129(1), 25-29. https://doi.org/10.1016/j.anchir.2003.11.011

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Ali H Abdelaal

  Faculty of Medicine, Aswan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants agreed to participate in the study and undergo the LC
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate and Resident of General Surgery

Model Details: comparing the efficacy of intra-operative Gallbladder content aspiration in overdistended cases with completion of the operation without aspiration

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 30, 2026
• Study Start: July 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)