Acute AppendicitisPhase 2NCT02789865
Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
A Phase 2 study testing Ertapenem, Levofloxacin and Metronidazole, Endoscopic retrograde appendicitis therapy (ERAT) and Appendectomy in people with Acute Appendicitis, run by First Affiliated Hospital Xi'an Jiaotong University at 3 sites in China.
Trial summary
Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic endoscopic retrograde appendicography (ERA) imaging… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Ertapenem, Levofloxacin and Metronidazole, Endoscopic retrograde appendicitis therapy (ERAT) and Appendectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- May 2016to Apr 2019
- Phase
- Phase 2
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with Alvarado scores ≥7 (with or without US/CT) diagnosed of uncomplicated acute appendicitis
- patients with Alvarado scores <7 but US/CT suggested uncomplicated acute appendicitis or could not exclude acute appendicitis.
Who cannot join
- perforated appendicitis
- periappendiceal abscess
- contraindications for colonoscopy
- allergy to contrast media or iodine
- pregnancy
- unable to cooperate or provide informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites
3201 Hospital of Hanzhong
Hanzhong, Shaanxi, 723000
Zhufang Ma, MD, 0086-18292172137, 1304101066@qq.com
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Yingchao Li, MD,PhD, 0086-18991232662, lych123@126.com
About this study
Official title: Multicenter Prospective Randomized Clinical Trial Comparing Endoscopic Retrograde Appendicitis Therapy (ERAT) vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute appendicitis, the procedures to relieve the appendiceal lumen obstruction including appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever necessary will be carried out. In this multicenter prospective randomized clinical trial, the patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group. The primary outcome is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time, duration of fever, duration of leukocytosis, bed time, rate of complication, rate of recurrence and rate of appendectomy during follow-up period of 1 year.
Read the detailed description
Intervention
The patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group.
- ERAT group: In preparation for ERAT, low-pressure cleansing enemas (500 mL normal saline solution per enema) will be administered for three times before the procedures for bowel preparation. Antibiotic therapy (levofloxacin + metronidazole) will be intravenously administrated to the patients in the perioperative period.
The procedures of ERAT will be performed as below：
- Cannulation of the appendiceal lumen: Colonoscopic examination under direct vision of the whole colon, ileocecal junction and terminal ileum will be performed to exclude other abnormalities first, and focus on the appendiceal orifice and the surrounding mucosa. Colonoscope attached by a transparent cap will be positioned close to the appendiceal orifice. Gerlach's valve will be pushed aside using the transparent cap, a standard catheter loaded with a 0.035-inch guidewire (loop-tip or hydrophilic-tip) will be placed in the appendiceal orifice. The guidewire will be probed gently to insert into the appendiceal lumen. The catheter will be then subsequently moved forward after the guidewire inserting deeply into the lumen under fluoroscopic guidance.
- Endoscopic retrograde appendicography (ERA): After cannulation of the appendiceal lumen, decompression of lumen will be achieved by suction using a 5-mL syringe attached to the catheter. A soluble contrast agent (iobitridol) will be then used to fill the appendix while being monitored by fluoroscopy to check the radiographic features of the appendix (including position, length, contour, mobility, intraluminal content and inner diameter of appendiceal lumen).
- Irrigation and appendicolith removal: The appendiceal lumen will be irrigated with normal saline solution to clear away the pus and the sand-like appendicoliths, while the large appendicoliths will be extracted using a balloon catheter or an extraction basket.
- Stenting for drainage: If the pus is massive or the lumen is stenosis, a plastic straight stent (8.5F) will be placed into the lumen over the guidewire for luminal decompression with the plan to retrieve the stent after about one week.
- Antibiotic therapy group: The patients will be treated with intravenous broad-spectrum antibiotics (Carbapenems) for 3 days and oral antibiotics (Levofloxacin and Metronidazole) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated.
- Appendectomy group: The patients will undergo laparoscopic appendectomy according to standard routines.
Follow-up and outcome measures
Follow-up will be performed until the end of the study period. The primary outcome is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time, duration of fever, duration of leukocytosis, bed time, rate of complication, rate of recurrence and rate of appendectomy during follow-up period of 1 year.
- Conditions
- Acute Appendicitis
- Being tested
- Ertapenem, Levofloxacin and Metronidazole, Endoscopic retrograde appendicitis therapy (ERAT), Appendectomy
- Keywords
- Acute appendicitis, Endoscopic retrograde appendicitis therapy, Endoscopic retrograde appendicography, Endoscopic therapy, Appendectomy, Antibiotic Therapy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertapenem, Levofloxacin and MetronidazoleDrug
The patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated.
Endoscopic retrograde appendicitis therapy (ERAT)Procedure or surgery
The procedures of ERAT will be performed as below：1.Cannulation of the appendiceal lumen. 2.Endoscopic retrograde appendicography (ERA). 3.Irrigation and appendicolith removal. 4.Stenting for drainage.
AppendectomyProcedure or surgery
The patients will receive laparoscopic appendectomy according to standard routines.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic therapy group | Active comparator | The patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated. Receives: Drug: Ertapenem, Levofloxacin and Metronidazole |
| ERAT group | Experimental | The patients will receive emergent endoscopic retrograde appendicitis therapy (ERAT). Receives: Procedure: Endoscopic retrograde appendicitis therapy (ERAT) |
| Appendectomy group | Active comparator | The patients will receive laparoscopic appendectomy according to standard routines. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of abdominal pain
Measured: up to 10 days
Secondary outcomes (7)
mean hospital stay
Measured: up to 10 days
duration of fever
Measured: up to 10 days
duration of leukocytosis
Measured: up to 10 days
bed time
Measured: up to 10 days
rate of complication
Measured: during follow-up period of 1 year
rate of recurrence
Measured: during follow-up period of 1 year
rate of appendectomy
Measured: during follow-up period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 3201 Hospital in Hanzhong, Second Affiliated Hospital of Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- Yingchao Li, MD,PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789865
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-010
- Status last verified
- Apr 2016
- First submitted
- 24 Apr 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.
PubMed 21550483Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.
PubMed 26080338Liu BR, Ma X, Feng J, Yang Z, Qu B, Feng ZT, Ma SR, Yin JB, Sun R, Guo LL, Liu WG. Endoscopic retrograde appendicitis therapy (ERAT) : a multicenter retrospective study in China. Surg Endosc. 2015 Apr;29(4):905-9. doi: 10.1007/s00464-014-3750-0. Epub 2014 Aug 9.
PubMed 25106722
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Clinical Trial Comparing Endoscopic Retrograde Appendicitis Therapy (ERAT) vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis
- ClinicalTrials.gov ID
- NCT02789865
- Acronym / sponsor ID
- XJTU1AF-CRF-2015-010
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Endoscopic retrograde appendicitis therapy, Endoscopic retrograde appendicography, Endoscopic therapy, Appendectomy, Antibiotic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- 3201 Hospital in Hanzhong, Second Affiliated Hospital of Xi'an Jiaotong University
- Study start
- May 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- 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.
Endoscopic retrograde appendicitis therapy (ERAT) is a new and minimally invasive method for the diagnosis and treatment of acute appendicitis.After a positive diagnosis of acute appendicitis is established by either colonoscopic direct-vision imaging or fluoroscopic endoscopic retrograde appendicography (ERA) imaging in patients with suspected acute appendicitis, the procedures to relieve the appendiceal lumen obstruction including appendiceal luminal irrigation, appendicolith removal, and stenting for drainage whenever necessary will be carried out. In this multicenter prospective randomized clinical trial, the patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group. The primary outcome is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time, duration of fever, duration of leukocytosis, bed time, rate of complication, rate of recurrence and rate of appendectomy during follow-up period of 1 year.
Detailed description
Intervention
The patients with uncomplicated acute appendicitis will be divided into three groups randomly: ERAT group, antibiotic therapy group and appendectomy group.
- ERAT group: In preparation for ERAT, low-pressure cleansing enemas (500 mL normal saline solution per enema) will be administered for three times before the procedures for bowel preparation. Antibiotic therapy (levofloxacin + metronidazole) will be intravenously administrated to the patients in the perioperative period.
The procedures of ERAT will be performed as below：
- Cannulation of the appendiceal lumen: Colonoscopic examination under direct vision of the whole colon, ileocecal junction and terminal ileum will be performed to exclude other abnormalities first, and focus on the appendiceal orifice and the surrounding mucosa. Colonoscope attached by a transparent cap will be positioned close to the appendiceal orifice. Gerlach's valve will be pushed aside using the transparent cap, a standard catheter loaded with a 0.035-inch guidewire (loop-tip or hydrophilic-tip) will be placed in the appendiceal orifice. The guidewire will be probed gently to insert into the appendiceal lumen. The catheter will be then subsequently moved forward after the guidewire inserting deeply into the lumen under fluoroscopic guidance.
- Endoscopic retrograde appendicography (ERA): After cannulation of the appendiceal lumen, decompression of lumen will be achieved by suction using a 5-mL syringe attached to the catheter. A soluble contrast agent (iobitridol) will be then used to fill the appendix while being monitored by fluoroscopy to check the radiographic features of the appendix (including position, length, contour, mobility, intraluminal content and inner diameter of appendiceal lumen).
- Irrigation and appendicolith removal: The appendiceal lumen will be irrigated with normal saline solution to clear away the pus and the sand-like appendicoliths, while the large appendicoliths will be extracted using a balloon catheter or an extraction basket.
- Stenting for drainage: If the pus is massive or the lumen is stenosis, a plastic straight stent (8.5F) will be placed into the lumen over the guidewire for luminal decompression with the plan to retrieve the stent after about one week.
- Antibiotic therapy group: The patients will be treated with intravenous broad-spectrum antibiotics (Carbapenems) for 3 days and oral antibiotics (Levofloxacin and Metronidazole) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated.
- Appendectomy group: The patients will undergo laparoscopic appendectomy according to standard routines.
Follow-up and outcome measures
Follow-up will be performed until the end of the study period. The primary outcome is duration of abdominal pain. The secondary outcomes include mean hospital stay, mean operative time, duration of fever, duration of leukocytosis, bed time, rate of complication, rate of recurrence and rate of appendectomy during follow-up period of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibiotic therapy group | Active comparator | Drug: Ertapenem, Levofloxacin and MetronidazoleThe patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated. |
| ERAT group | Experimental | Procedure: Endoscopic retrograde appendicitis therapy (ERAT)The patients will receive emergent endoscopic retrograde appendicitis therapy (ERAT). |
| Appendectomy group | Active comparator | Procedure: AppendectomyThe patients will receive laparoscopic appendectomy according to standard routines. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with Alvarado scores ≥7 (with or without US/CT) diagnosed of uncomplicated acute appendicitis
- patients with Alvarado scores <7 but US/CT suggested uncomplicated acute appendicitis or could not exclude acute appendicitis.
Key exclusion criteria (6 listed)
- perforated appendicitis
- periappendiceal abscess
- contraindications for colonoscopy
- allergy to contrast media or iodine
- pregnancy
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 |
|---|---|---|
| Ertapenem, Levofloxacin and MetronidazoleThe patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated. | Drug | Antibiotic therapy group |
| Endoscopic retrograde appendicitis therapy (ERAT)The procedures of ERAT will be performed as below：1.Cannulation of the appendiceal lumen. 2.Endoscopic retrograde appendicography (ERA). 3.Irrigation and appendicolith removal. 4.Stenting for drainage. | Procedure or surgery | ERAT group |
| AppendectomyThe patients will receive laparoscopic appendectomy according to standard routines. | Procedure or surgery | Appendectomy group |
Primary outcome
duration of abdominal pain
Time frame: up to 10 days
7 secondary outcomes
mean hospital stay
Time frame: up to 10 days
duration of fever
Time frame: up to 10 days
duration of leukocytosis
Time frame: up to 10 days
bed time
Time frame: up to 10 days
rate of complication
Time frame: during follow-up period of 1 year
rate of recurrence
Time frame: during follow-up period of 1 year
rate of appendectomy
Time frame: during follow-up period of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Background: PubMed 21550483Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.
- Background: PubMed 26080338Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.
- Background: PubMed 25106722Liu BR, Ma X, Feng J, Yang Z, Qu B, Feng ZT, Ma SR, Yin JB, Sun R, Guo LL, Liu WG. Endoscopic retrograde appendicitis therapy (ERAT) : a multicenter retrospective study in China. Surg Endosc. 2015 Apr;29(4):905-9. doi: 10.1007/s00464-014-3750-0. Epub 2014 Aug 9.
- Individual participant dataSharing planned: Undecided
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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.
Yingchao Li, MD,PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ertapenem, Levofloxacin and Metronidazole, Endoscopic retrograde appendicitis therapy (ERAT) and Appendectomy in people with Acute Appendicitis, run by First Affiliated Hospital Xi'an Jiaotong University at 3 sites in China.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingchao Li, MD,PhD (0086-18991232662, lych123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of abdominal pain (time frame: up to 10 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 NCT02789865, which also lists 3 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 3 Jun 2016.