Clinical trial NCT04714021: CO2 vs Air Insufflation in Children Undergoing PEG
Official title: CO2 vs Air Insufflation in Children Undergoing PEG (CO2pegA) - a Multicenter Double Blind RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrostomy
Keywords: children
endoscopy
CO2 insufflation
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: European Society of Pediatric Gastroenterology, Hepatology and Nutrition
First posted: 2021-01-19
Enrollment: 120
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * single step PEG technique group divided to co2 or air insufflation group during endoscopy
* pull technique PEG group divided to co2 or air insufflation group during endoscopy
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.

Detailed description: Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.

The primary objective is to determine the safety of the CO2 insufflation during PEG. The secondary objective of this study is to investigate the inhibitory effect of CO2 insufflation on bowel distension.

This is an investigator initiated multicentre, randomized, double blind study to evaluate the safety and adverse events profile of CO2 insufflation during PEG procedure. The study included a screening, pre-intervention (pre-PEG) and a post-intervention time (after-PEG), with total of 4 measurements of waist circumference, two measurements of i-stat.

Children aged 0-19 years, who were admitted for PEG procedure and who meet all inclusion and none of the exclusion criteria listed below. A total of 120 children after PEG insertion will be included and divided in two groups: one step group and standard pull group of children; two established groups will be randomized 1:1.

Inclusion criteria

* Male or female patients
* Age between 0 - 19 years
* Written informed consent Exclusion criteria
* Absolute contraindication for PEG procedure
* Patients with hypercapnia (pCO2 \> 50 mmHg at first i-stat measurement)
* Language barriers which do not allow to give informed consent Patient data will be collected: age, gender, body mass index (BMI), underlining disease, duration of procedure, type of procedure, type of the scope, type of sedation or anaesthesia, complications.

Due to study protocol capillary blood will be withdrawn twice. To conclude there are actually no additional risks for included children due to the study protocol. Moreover, we will be able to diagnose early the important pneumoperitoneum, if it will occur and start to treat it with effective pain killers.

Eligibility criteria: Inclusion Criteria:

* Male or female patients indicated for PEG procedure
* Age between 0 - 19 years
* Written informed consent

Exclusion Criteria:

* Absolute contraindication for PEG procedure
* Patients with hypercapnia (pCO2 \> 50 mmHg at first i-stat measurement)
* Language barriers which do not allow to give informed consent

Primary outcomes:
measure: To asses the change in pCO2 before and after the procedure
timeFrame: Time 0- (before the procedure) and at time 30 minutes (approximate end of procedure)
Secondary outcomes:
measure: To asses the change in waist circumference comparing CO2 and air insufflation
timeFrame: at four different time points: at time 0 (just before the procedure), 10 minutes later, 120 minutes later and 240 minutes later
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Paediatric Gastroenterology-Hepatology, Queen Fabiola Children's University Hospital
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
city: Messina
country: Italy
facility: Policlinico Universitario Messina
city: Ljubljana
country: Slovenia
facility: University Children's Hospital
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
city: Dubai
country: United Arab Emirates
facility: Al Jalila Children's Specialty Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Children's Hospital in Ljubljana
name: Matjaz Homan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Children's Hospital
name: Mike Thomson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
citation: Thomson M, Rao P, Rawat D, Wenzl TG. Percutaneous endoscopic gastrostomy and gastro-oesophageal reflux in neurologically impaired children. World J Gastroenterol. 2011 Jan 14;17(2):191-6. doi: 10.3748/wjg.v17.i2.191.
citation: Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.
citation: Maple JT, Keswani RN, Hovis RM, Saddedin EZ, Jonnalagadda S, Azar RR, Hagen C, Thompson DM, Waldbaum L, Edmundowicz SA. Carbon dioxide insufflation during ERCP for reduction of postprocedure pain: a randomized, double-blind, controlled trial. Gastrointest Endosc. 2009 Aug;70(2):278-83. doi: 10.1016/j.gie.2008.12.050. Epub 2009 Jun 11.