Pylorus resection versus pylorus preservation in pancreatoduodenectomy: A multicenter surgical registry-based randomized active-controlled trial (RRCT) from the German DGAV StuDoQ|Pancreas Registry

Not Applicable

Recruiting

• Conditions: K31.9; T81.9; Disease of stomach and duodenum, unspecified; Unspecified complication of procedure

• Registration Number: DRKS00018842
• Lead Sponsor: MU Klinikum München Anstalt des öffentlichen Rechts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 982

Inclusion Criteria

Patients in which a partial pancreatoduodenectomy (PD) needs to be performed
Any patient aged 18 years or older scheduled for PD for any indication with written informed consent is eligible

Exclusion Criteria

-Patients who participate in another intervention trial interfering with the surgical intervention or the outcome of this Trial
-Patients with expected lack of compliance and/or irreconcilable language barriers will be excluded
-Classic Whipple operation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint is the frequency of postoperative DGE (delayed gastric emptying) according to the international ISGPS definition 30 days after index operation, compared between the two intervention groups

Secondary Outcome Measures

Name	Time	Method
severe morbidity (Clavien Dindo classification<3b vs =3b), blood loss (ml), 30 day mortality (death from any cause), postoperative hospital stay, insufficiency of the gastro/pylorojejunostomy, operation time, initiation of adjuvant chemotherapy in cancer patients