Autotransplantation of the spleen after distal pancreatectomy and splenectomy for benign lesions of the distal pancreas, will it restore the function of the spleen?

Not Applicable

Completed

• Conditions: Autogenic splenic implantation to prevent hyposplenism following distal pancreatectomy for benign neoplasm of the pancreas; Surgery

• Registration Number: ISRCTN10171587
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38195501/ (added 10/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Study Completion: 2023-07-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Current inclusion criteria as of 08/06/2022:
1. Adults
2. Indication for distal pancreatectomy for suspected benign lesion
3. Either spleen-preserving or with splenectomy
4. Either laparoscopic or robotic procedures
5. Fit to undergo distal pancreatectomy (American Society of Anaesthesiologists classification of 3 or below)

Previous inclusion criteria:
1. Adults
2. Indication for distal pancreatectomy for suspected benign lesion
3. Either spleen-preserving or with splenectomy
4. Either open or laparoscopic
5. Fit to undergo distal pancreatectomy (American Society of Anaesthesiologists classification of 3 or below)

Exclusion Criteria

1. Proven or suspected malignant lesion of the pancreatic body or tail
2. Asplenia, either functional, surgical or congenital
3. Any other known immune deficiency disorder
4. Known allergy to any of the Typhim Vi vaccine containing components
5. Pregnancy
6. Unfit to undergo distal pancreatectomy (American Society of Anaesthesiologist classification above 3)
7. Prisoners and adults lacking capacity to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunologic splenic function assessed using levels of Salmonella typhi specific antibodies (Ab) prior to and after vaccination with the Typhim Vi™ polysaccharide vaccine. The levels of Salmonella typhi specific of Ab raised in response to the Typhim Vi™ polysaccharide vaccine will be measured by using the Salmonella typhi Vi IgG ELISA Assay. Pre-vaccination levels will be measured at 6 months postoperatively and post-vaccination levels at 7 months postoperatively.

Secondary Outcome Measures

Name	Time	Method
1. 30-day mortality, described as mortality during initial hospitalisation or within 30 days postoperative, measured daily as long as participant is in hospital, thereafter at 2 weeks and 6 weeks after discharge<br>2. 30-day postoperative complication rate, the occurrence of any postoperative complication, measured daily as long as participant is in hospital, thereafter at 2 weeks and 6 weeks after discharge<br>3. Hospital stay, described as number of postoperative days in hospital, measured once after discharge<br>4. Operating time, described as number of minutes from incision to closure of skin, measured once after the operation<br>5. Estimated blood loss, described as the estimated blood loss during the operation, measured once after the operation<br>6. Blood transfusion required, described as any blood transfusion given during the operation of after during initial hospitalisation, measured once after discharge