The effect of an additional Braun anastomosis in patients after pancreas head resections

Phase 3

Recruiting

• Conditions: C24.8; C24.9; K86.8; K86.9; Other chronic pancreatitis; Head of pancreas; Body of pancreas; Alcohol-induced chronic pancreatitis; Extrahepatic bile duct; Ampulla of Vater

• Registration Number: DRKS00024364
• Lead Sponsor: Klinikum Rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

1. Patients with benign or malignant diseases of the pancreas, the distal bile duct and the duodenum requiring a pylorus-preserving pancreaticoduodenectomy
2. Surgical reconstruction by Child reconstruction defined as pancreaticojejunostomy followed by hepaticojejunostomy followed by duodenojejunostomy
3. Age = 18 years.
4. Ability to understand the character and individual consequences of the trial and to sign the informed consent

Exclusion Criteria

1. Patients undergoing classical Kausch-Whipple resection
2. Patients undergoing pylorus-preserving pancreaticoduodenectomy with requirement of intraoperative arterial resection
3. Patients with pylorus-preserving pancreaticoduodenectomy with requirement of multivisceral resections
4. Laparoscopic or laparoscopic-assisted pancreatic surgery
5. Distal pancreatectomy
6. Enucleations
7. Patients after previous major GI-surgery in medical history
8. Pregnant or breast-feeding women
9. Planned re-laparotomy up to 30 days after initial surgery
Emergency surgery

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of clinically relevant POPF according to the current definition of the International Study group of Pancreatic surgery (ISGPS) within a postoperative period of 30 (+10) days

Secondary Outcome Measures

Name	Time	Method
1. Incidence and severity of clinically relevant postoperative delayed gastric emptying according to ISPGS-definition (30 POD)<br>2. Incidence and severity of postoperative haemorrhages according to ISGPS-definition (30 POD)<br>3. Incidence and severity of postoperative complications according to the Clavien-Dindo classification within 30 days after surgery<br>5. Complication comprehensive index after operation during hospital stay<br>6. In-hospital, 30- and 90-day mortality rates<br>7. Incidence of reoperations and reinterventions <br>8. Incidence of anastomotic leaks of the Braun enteroenterostomy<br>9. Quality of life after pancreas resection (EORTC QLQ-C30)<br>10. Length of hospital stay (measured between day 0 of the operation and discharge)<br>11. Length of stay on ICU (measured from day 0 of the operation)<br>12. Histopathological tumor stage<br>13. Postoperative pain according to the Visual Analogue Scale (VAS 0-10) <br>14. Incidence of re-admission within the duration of the study after discharge