Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia

Esophageal Achalasia Clinical Trial

Official title:

Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia: A Triple-Blind, Randomized Controlled, Non-Inferiority Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03404739
• Other study ID #: ABX for POEM
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2017
• Est. completion date: January 2019

Study information

• Verified date: January 2018
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peroral endoscopic myotomy is a novel, promising endoscopic technique for achalasia considering its minimal invasive characteristics and comparable efficacy to Heller myotomy. Numerous studies have focused on the efficacy, safety as well as technical aspects of POEM. However, few efforts have been made to the issue of antimicrobial prophylaxis in POEM. Postoperative prophylactic antibiotics are universally initiated on call to the operating room or at the start of POEM and consist of second-generation cephalosporins. The mean duration of antibiotic regimen after POEM was 3 days ranging from 1 day to 7 days.

Numerous studies have shown that a single dose of antibiotic prophylaxis in a variety of surgical procedures. Other studies have shown that prolonged administration of antibiotics for longer than 24 hours add no benefit in many surgeries. Prolonged use of antibiotics not only increases the costs and exposure to drug toxicity directly but also may be associated with an increased risk of acquired antibiotic resistance as well as infection with Clostridium difficile.

Thus, investigators intend to perform a prospective randomized study to confirm the validity of single-dose antimicrobial prophylaxis for the prevention of infectious complications following peroral endoscopic myotomy.

Description:

This prospective randomized trial is performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of infectious complications associated with peroral endoscopic myotomy. Six hundred sixty-six patients undergoing POEM for achalasia will be randomized to receive only single-dose ceftazidime (2g) or an additional 2 doses every 12 hours postoperatively (multi-dose group). POEM associated infectious complications will be assessed and recorded as regional infections, remote infections and systemic infections. Infection rate, adverse events related to antibiotics and POEM, Clavien-Dindo classification of surgical complications, length of hospital stay and efficacy of POEM will be compared. Body fluid bacterial culture will be conducted in patients suspected of infectious complications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 666
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed of esophageal achalasia

• Patients or legal surrogates willing and competent to give informed consent and to comply with follow up visits and tests

Exclusion Criteria:

• Patients with ASA score =3

• Patients with indications for antibiotic prophylaxis(infective endocarditis or other conditions) as determined by the American Society for Gastrointestinal Endoscopy

• Patients who have received antibiotics in the past seven days

• Patients who have possible signs of infection during preparation for POEM

• Pregnant

• Immunodeficient patients such as severe neutropenia(<0.5x1068/l) and/or advanced hematological malignancy

• Under steroid therapy

• Patients who develop intraoperative severe adverse events including severe choking and aspiration during endotracheal intubation requiring antibiotic treatment as well as severe pneumothorax, perforation, bleeding and mucosal injury cannot be closed by clips.

Related Conditions & MeSH terms

• Communicable Diseases
• Esophageal Achalasia
• Infection

Intervention

Drug:
• Saline Solution
These patients will be given only one dose of ceftazidime at the start of POEM plus 2 doses of saline solution every 12 hours after the procedure.
• Ceftazidime
These patients will be given ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

ASGE Standards of Practice Committee, Khashab MA, Chithadi KV, Acosta RD, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Cash BD. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81(1):81-9. doi: 10.1016/j.gie.2014.08.008. Epub 2014 Nov 11. Review. — View Citation

Imamura H, Kurokawa Y, Tsujinaka T, Inoue K, Kimura Y, Iijima S, Shimokawa T, Furukawa H. Intraoperative versus extended antimicrobial prophylaxis after gastric cancer surgery: a phase 3, open-label, randomised controlled, non-inferiority trial. Lancet Infect Dis. 2012 May;12(5):381-7. doi: 10.1016/S1473-3099(11)70370-X. Epub 2012 Jan 31. — View Citation

Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. — View Citation

Mohri Y, Tonouchi H, Kobayashi M, Nakai K, Kusunoki M; Mie Surgical Infection Research Group. Randomized clinical trial of single- versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery. Br J Surg. 2007 Jun;94(6):683-8. — View Citation

Stavropoulos SN, Modayil RJ, Friedel D, Savides T. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc. 2013 Sep;27(9):3322-38. doi: 10.1007/s00464-013-2913-8. Epub 2013 Apr 3. — View Citation

Zhang XC, Li QL, Xu MD, Chen SY, Zhong YS, Zhang YQ, Chen WF, Ma LL, Qin WZ, Hu JW, Cai MY, Yao LQ, Zhou PH. Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis. Endoscopy. 2016 Nov;48(11):967-978. Epub 2016 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications associated with POEM	Including regional, remote and systemic infections.	From operation day to 4 weeks after the procedure
Secondary	Pathogens for causing infection	Body fluid will be collected and cultured in patients suspected of infectious complications	From operation day to 4 weeks after the procedure
Secondary	Adverse effects of antibiotics	Any adverse events related to ceftazidime will be recorded.	From operation day to 4 weeks after the procedure
Secondary	Clavien-Dindo classification of surgical complications	Clavien-Dindo classification of surgical complications is recorded if adverse events happen related to POEM	From operation day to 4 weeks after the procedure
Secondary	Length of hospital stay	Length of hospital stay will be extracted.	From admission to discharge
Secondary	Efficacy of POEM	Eckardt score will be compared before and after POEM.Clinical scoring system for achalasia (Eckardt score) Score Symptom Weight loss (kg)(0-3), Dysphagia(0-3), Retrosternal pain(0-3), Regurgitation(0-3)	admission to 4 weeks after POEM