Prospective pilot study: Comparison of the effectiveness and safety of two different systems for placing a direct puncture PEG with gastropexy

Prospective pilot study: Comparison of the effectiveness and safety of two different systems for placing a direct puncture PEG with gastropexy - Gastropex study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038331

Enrollment

Registered

2025-10-31

Start date

2025-11-03

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PEG tube placement with gastropexy

Interventions

Group 1: Placement of a direct puncture PEG with gastropexy (Freka Pexact (System A)) Group 2: Placement of a direct puncture PEG with gastropexy (Avanos-PEG (System B))

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Indication for PEG placement using direct puncture technique independent of this study (i.e. patients with long-term inability to consume sufficient oral nutrition + oesophageal stenosis or carcinomas in the head/neck or oesophagus area that cannot be passed with a standard gastroscope with a potentially curative therapeutic approach) -Voluntary participation -Capacity to give consent -Signed declaration of consent for this study -Legal age

Exclusion criteria

Exclusion criteria: -Patients younger than 18 years of age -Patients incapable of giving consent -Lack of consent -Large amount of ascites (clinically detectable ascites) -Post-gastrectomy -Post-oesophagectomy with gastric pull-up

Design outcomes

Primary

Measure	Time frame
Duration of the installation procedure	—

Secondary

Measure	Time frame
1. Rate of major complications within 14 days of PEG placement (period: 14 days) 2. Rate of minor complications within 14 days of PEG placement (period: 14 days) 3. Hospital days after placement 4. Propofol consumption + consumption of other anaesthetic drugs 5. Material consumption costs 6. Body weight change after 14 days (period: 14 days) 7. Technical success rate 8. Quality of life (standardised questionnaire before PEG and 14 days after placement) Major complications: -Peritonitis with/without pneumoperitoneum -Tube dislocation into the abdominal cavity -Bleeding requiring intervention/transfusion -Necrotising fasciitis -Buried bumper syndrome -Intestinal perforation -Phlegmon -Abscess Minor complications: -Wound infection -Stoma leakage -Pneumoperitoneum (after day 3) without peritonitis -Bleeding without need for intervention -Unintentional PEG removal -Pain (NRS from 5/10 or additional analgesic requirement) -Radiological follow-up examination	—

Measure

Time frame

1. Rate of major complications within 14 days of PEG placement (period: 14 days) 2. Rate of minor complications within 14 days of PEG placement (period: 14 days) 3. Hospital days after placement 4. Propofol consumption + consumption of other anaesthetic drugs 5. Material consumption costs 6. Body weight change after 14 days (period: 14 days) 7. Technical success rate 8. Quality of life (standardised questionnaire before PEG and 14 days after placement) Major complications: -Peritonitis with/without pneumoperitoneum -Tube dislocation into the abdominal cavity -Bleeding requiring intervention/transfusion -Necrotising fasciitis -Buried bumper syndrome -Intestinal perforation -Phlegmon -Abscess Minor complications: -Wound infection -Stoma leakage -Pneumoperitoneum (after day 3) without peritonitis -Bleeding without need for intervention -Unintentional PEG removal -Pain (NRS from 5/10 or additional analgesic requirement) -Radiological follow-up examination

—

Countries

Germany

Contacts

Public ContactGolo Petzold

Universitätsmedizin Göttingen

golo.petzold@med.uni-goettingen.de+49 5513962313

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026