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Table 2 Schedule of treatments. X demarcates the trial intervention

From: PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Visit

Screening

Visit1 (enrolment)

Visit 2 (Randomisation)

Post-operative days 4 and 6

Post operative days 3, 5 and 7

Visit 3 (discharge)

Visit 4 (3m FU)

Visit 5 (6m FU)

Visit 6 (12m FU)

End of Study

To assess eligibility only (no data to be collected until consent)

Within 4 weeks of surgery

Day of surgery (Day 0)

4 and 6 days post-surgery

3, 5 and 7 days post-surgery

Day of discharge

3 months post surgery (±4 weeks)

6 months post surgery (±4 weeks)

12 months post surgery (±4 weeks)

12 months post-surgery (or earlier due to other cause)

Assessments / Procedures

Written Informed Form

 

X1

        

Assessment of eligibility criteria

X

X

        

Suspected date of diagnosis

 

X

        

Demographics (height, weight, etc.)

 

X

   

X2

X2

X2

X2

 

Smoking and alcohol status

 

X

        

Review of Medical History (including symptoms and relevant tests)

 

X

        

Family Medical History

 

X

        

Pregnancy Test

 

X

        

Pancreatic Endocrine Insufficiency status

 

X

  

X

X

X

X

X

 

Diabetic status

 

X

   

X

X

X

X

 

Adverse events

    

X

X

X

X

X

 

Octreotide review3

  

X

X

X (Day 3 & 5)

     

Surgical drain review

  

X

X

X

X

X

   

Randomisation

  

X

       

CA19-9

  

X

       

Full blood count4

  

X

 

X (Day 5 ±2 days)

X (Day of discharge −2 days)

    

Serum Biochemistry5

  

X

 

X (Day 5 ±2 days)

X (Day of discharge −2 days)

    

Clotting screen6

  

X

 

X (Day 5 ±2 days)

X (Day of discharge −2 days)

    

Blood Sample for translational study7

  

X

 

X (Day 5 + 2days)

     

Histological sample for translational study8

  

X

       

Surgical Intervention

  

X

       

Details of surgery

  

X

       

Take Operative photographs

  

X

       

Upload Operative Photographs9

  

X

       

Operation time

  

X

       

Intra and post-operative bleeding assessment

  

X

 

X

X

    

Post- operative fluid collection

   

X

X

X

X

   

Survival status10

    

X

X

X

X

X

X

Delayed gastric emptying assessment

    

X

X

    

Re-operation review

    

X

X

X

X

X

 

Pulmonary infection assessment

     

X

X

   

Surgical site infections assessment

    

X

X

X

X

X

 

Venous thrombo-embolism assessment

    

X

X

X

X

X

 

Fluid collection review (to assess POPF)

   

X

X

X

X

   

Length of initial hospital stay

     

X

    

Re-admission review

      

X

X

X

 

Adjuvant therapy review

      

X

X

X

 

QoL11

 

X

   

X

X

X

X

 

Reason for end of study

         

X

  1. 1. Patient consent does not need to be within 4 weeks of surgery
  2. 2. At discharge and follow up weight only to be recorded
  3. 3. Initial dose of Octreotide (100ug) to be administered on the evening before surgery (if applicable) then 100ug 3 times daily on the day of surgery and post-operative days 1 to 6
  4. 4. FBC (haemoglobin, platelets, absolute neutrophil count, white blood cell count, eosinophils, basophils, lymphocytes, monocytes) to be done pre-operatively either the evening before or morning of surgery and post-operatively on day 5. A window of ±2 days applies to day 5 FBC only and a −2 day window applies at day of discharge
  5. 5. Serum biochemistry (sodium, potassium, calcium, urea, creatinine, eGFR, random glucose, albumin, bilirubin, alk.phosphatase, total protein, AST or ALT, GGT and CRP) to be done pre-operatively either the evening before or morning of surgery and post-operatively on day 5. A window of ±2 days applies to day 5 serum chemistry only and a −2 day window applied at day of discharge
  6. 6. Clotting screen (PT and APTT) to be done pre-operatively either on the evening before or morning of surgery and post-operatively on day 5. A window of ±2 days applies to day 5 clotting screen only and a −2 day window applies at day of discharge
  7. 7. Translational blood samples (10ml EDTA tube and 8.5ml SST tube) to be taken pre-operatively either on the evening before or morning of surgery and on post-operative day 5. A window of +2 days applies to the day 5 translational blood samples
  8. 8. Diagnostic H&E slide of the pancreatic neck transection margin will be requested for all patients along with a histological report by the LCTU on a 6 monthly basis. Slides will be held for the duration of the trial and returned at the end
  9. 9. Operative photographs should be uploaded on to the LCTU portal immediately after surgery
  10. 10. Death due to any cause must be reported by completing an End of Study Form
  11. 11. EORTC QLQ-C30 and EQ-5D and EQ-VAS to be completed
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