Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study
Phase: NA
Conditions: Pancreatic Neoplasms, Laparoscopic Pancreaticoduodenectomy, Whipple Operation
Sponsor: Cairo University

                                                                                                           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Official title : Total 
laparoscopic versus open 
pancreaticoduodenectomy: 
a prospective comparative 
randomized clinical study 
 
 
NCT Number : Not yet assigned 
  
Document Date : 1/9/2022 
 
 
 
 
 
 

                                                                                                           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Faculty of Medicine, Cairo University Postgraduate 
Research Protocol Template 
 
1. Study 
 
a- Proposed Study Title:   
Total laparoscopic versus open pancreaticoduodenectomy: a prospective 
comparative randomized clinical study 
 دراسة استباقية لمقارنة اوجه الفروق بين
استئصال اورام البنكرياس واالثنى عشر بالمنظار او الفتح الجراحي 
 
b- Degree:  MD                   
c- Date of Registration of MD: Jan 2022 
 
 
 
 
3. Scientific committee approval :   
Date of approval: 1/9/2022 , code MD-196-2022 
 

                                                                                                           
 
 
 
4. Background and Rationale:   
     Total laparoscopic pancreaticoduodenectomy (TLPD) remains one of the most advanced 
laparoscopic procedures. Owing to the evolution in laparoscopic technology and instrumentation 
within the past decade, laparoscopic pancreaticoduodenectomy is beginning to gain wider 
acceptance.(1) 
Gagner and Pomp were the first to describe the laparoscopic Whipple procedure in 1994.3 The long 
operative times and technical difficulties coupled with the need to develop advanced laparoscopic 
skills1,2 were valid reasons that supported the initial reluctance to pursue these sophisticated 
minimally invasive operations. Recently, laparoscopic pancreaticoduodenectomy has started to gain 
wider acceptance as surgeons become more comfortable with laparoscopic technology. As a result, 
TLPDs have been reported with an increased frequency from institutions internationally.(2-15) 
In recent years, total laparoscopic pancreaticoduodenectomy (TLPD) has been introduced as a 
feasible alternative to open pancreaticoduodenectomy (OPD) when performed by experienced 
surgeons in laparoscopic and pancreatic surgery. Its application has been gradually increased, but its 
safety, reproducibility, and oncological outcomes are still debated due to its technical complexity and 
prolonged operating time. There are different experiences present in the literature regarding 
indications, surgical techniques, postoperative outcomes, benefits and limitations of this approach, 
oncological results, learning curve, and costs. There is no standardized surgical technique for TLPD. 
Different techniques exist for both the demolitive stage and the reconstructive stage. We summarized 
the different aspects of the surgical technique based on the various experiences reported by different 
authors. Compared to OPD, TLPD provides the advantages of laparoscopy, i.e., reduced blood loss, 
decreased postoperative pain, and shorter length of hospital stay, without increasing the rate of 
postoperative complications or compromising oncological outcomes. With increased experience, 
more challenging cases may also be approached with this technique, including those requiring major 
vascular resections or multi-visceral resections.(16) 
Pancreaticoduodenectomy (PD) has seen improved perioperative outcomes and complication rates 
over the last few decades (17-20). Nevertheless, it continues to be a morbid operation with 
complications ranging from 24-59% (21-23). Laparoscopic surgery reduces surgical morbidity in 
various operations, however laparoscopic pancreaticoduodenectomy (LPD) is a relatively new 
procedure which lacks a clear consensus regarding its benefits (24-28). Although the first published 
case was described in 1994, it has been slow to gain popularity (29). This is likely in part due to the 
challenging technical aspect of the procedure including the retroperitoneal location of the pancreas, 
close vicinity to the superior mesenteric artery and vein, portal vein and hepatic arteries and the 
technical difficulty of three anastamosis. In recent years, however, we have seen an increasing 

                                                                                                           
 
 
number of studies examining LPD. Initial research evaluated feasibility and outcomes, assessing 
whether LPD could be done with adequate safety (30-37). The question then moved to compare to 
the open approach questioning if it will it appreciate the same benefits of other laparoscopic 
surgeries. Partially enabled by higher volumes at specialized centers, studies began comparing LPD 
with (OPD). Although there are a handful of pancreaticoduodenectomy review articles evaluating 
LPD in the literature, many include papers with limited sample sizes and case reports. Our goal in 
this study is to compare and contrast the outcomes of both approaches aiming to reduce post 
operative morbidity and oncological outcomes. 
     
5. Objectives:  
 
The study aims to determine the advantages and disadvantages of performing total 
laparoscopic pancreaticoduodenectomy over the open approach and to compare the 
outcomes aiming to reduce the magnitude of operative morbidity. 
 
6. Study Design: 
               
                Prospective comparative randomized clinical study 
o Study Methods 
o Population of study:  
Patients presenting to Kasr Al-Ainy hospital requiring pancreaticoduodenectomy 
o Study location: 
            Kasr AlAiny Hospitals – Cairo University 
- 
Inclusion criteria:  
o Patients presenting with pancreatic head tumours, cholagiocarcinoma, duodenal 
tumours (1st, 2nd and 3rd part) and ampullary tumours who are fit for either open 
or laparoscopic pancreaticoduodenectomy  
      -    Exclusion criteria: 
       
o Patients who are deemed inoperable due to the presence of metastases 

                                                                                                           
 
 
o Patients with irresectable tumours 
 
- 
Methodology in details: 
 
o Patients will present to the outpatient clinic of Kasr Alainy hospitals with pancreatic head 
tumours, cholagiocarcinoma, duodenal tumours (1st, 2nd and 3rd part) and 
ampullary 
tumours 
who 
are 
fit 
for 
either 
open 
or 
laparoscopic 
pancreaticoduodenectomy. 
o Full assessment will be done by clinical examination, radiological assessment in the form 
of EUS, CT scan and metastatic work-up, laboratory investigations in the form of tumour 
markers and tissue biopsy histopathological examination.  
o Patients will be classified into frank resectable, bordeline resectable (defined as pancreatic 
head masses larger than 4 cm in size, equivocal findings of ascites and metastases on CT 
scan and signs of advanced disease as in marked weight loss and markedly elevated CA19-
9 > 1000) and frank irresectable. 
o A decision will be made by the multidisciplinary team and patients will be selected to 
undergo total laparoscopic pancreaticoduodenectomy or open pancreaticoduodenectomy 
through a randomized manner 
o Patients with tumours classified as borderline resectable tumours will be subjected to 
diagnostic laparoscpy prior to open suregry  
o A diagnostic survey and intraoperative ultrasonography were performed to assess for 
resectability and other pathological conditions such as the presence of ascites, liver 
metastases and peritoneal deposits and a decision to proceed or abort will be made 
accordingly. 
o Patients classified as bordeline resectable will undergo an intraoperartive ultrasound 
assesment of the vessel involvement, LNs and tumour size if irresectability is suspected. 
o Open approach will entail a roof top incision 
o Laparoscopic approach will entail trocar placement at the following sites: 
- 
10 mm visual port at the level of the umbilicus 
- 
12 mm port in the right mid-clavicular line 2 cm below the umbilicus 
- 
5 mm port in the left mid-clavicular line 2 cm below the umbilicus 
- 
5 mml port in the right mid-calvicular line 2 cm above the umbilicus 
- 
5 mml port in the left mid-clavicular line 2 cm above the umbilicus 
- 
An optional 5mm port in the epigastric region if required 
o Total internal stents will be placed inside the pancreatic and biliary anastomoses. The size 
of the stents will be determined according to caliber of pancreatic duct and common bile 
duct. 
o Operative time will be calculated in minutes starting from skin incision to skin closure  

                                                                                                           
 
 
o Blood loss will be assessed in coordination with the anaethesia team by counting the 
number of soaked towels and gauze and calculating the amount of blood suctioned through 
out the procedure. 
o Daily chest assessment to exclude or suspect lung atelectasis, pleural effusion or 
pneumonia will be done. Further chest imaging and will be done if required. 
o Daily serial abdominal examination to exclude or suspect pancreatic or biliary leakage will 
be done. Further laboratory assessment will be done if required (inflammatory markes: 
TLC, CRP, serum and drain amylase, serum and drain blilirubin), imaging in the form of 
an abdomen and pelvis CT study may be done if required. 
o Daily wound assesment will be done starting 48 hours following surgery 
o Pain assessment will done by means of a visual analogue scale (VAS) 
o Early patient satisfaction in terms of post operative pain, early ambulation, ability to 
resume daily activities and complicatons by means of a questionnaire 
o ICU stay and total hospital stay will be calculated 
o Pathological assessment will be noted in terms of number of Lns harvested and the 
resection margins (R0 or R1) 
o Incison / portsite examination to exclude incisional or portsite hernia. 
  
 
 
 
 
.    
o Does the research involve? 
          Human participants 
 
          Biological samples/Tissues 
 
          Identifiable private data/Information     
 
 
o Type of consent of study participants: 
 
    Written consent 
 
    Oral consent 
 

                                                                                                           
 
 
          No consent needed (Please justify) 
 
o Potential risks:  
 
                        No attributed risks can be related to the study 
 
o Confidentiality of data:  
All study related information will be stored securely at the study site.  
All participant information will be stored in locked file cabinets in areas with limited 
access. 
 Participants' study information will not be released outside the study without the written 
permission of the participant. 
Research ethics committee “REC” & Health authorities have the right to review’s 
patient’s data 
 
 
 
 
 
 
 
 
      9- Study outcomes: 
- 
Primary outcome:  
 
o Operative time 
o Assessment of early post-operative complications including: pain, respiratory 
complications (collapse, pleural effusion or pneumonia) 
o Incidence of pancreatic and biliary leakage 
 
   
- 
Secondary outcome:  
o ICU stay and total hospital stay 
o Patient satisfaction in terms of pain, ambulation, ability to resume daily routine 
activities 
o Blood loss and need for blood transfusion accordingly 

                                                                                                           
 
 
o Wound complications including: infection (early)  and incisional hernia/port site 
hernia (late) 
o Pathological assessment in terms of LN harvesting and resection margins (R0 
resection or R1) 
 
         10- Sample size  
               
The sample size was assessed using the G ∗ power 3.1.9.4 software (Universities Kiel, 
Germany). The calculation was based on the study of Ammori et al. [11], which 
reported a mean hospital stay length of 4.7 ± 1.125 days in the OPD group compared 
to a respective mean of 8.9 ± 5.425 days in the LPD group. After setting the study 
power at 80% and α at 0.05, a minimum of 12 patients in each group were required. 
 
 
  
 
 
         11- Statistical analysis  
        12- Source of funding:  
- No Funding  
       13- Time plan:  
              
             - When to start? After REC approval 
 
              - When expected to finish?  
 
              - When to publish? 
 
      
       14- References: 
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