Surgery and surgical disciplines have evolved over the past century. Advancements in surgical aids and perioperative care have greatly decreased morbidity and mortality. Advanced surgeries like pancreaticoduodenectomy (PD) are being performed routinely, even in older age patients with co-morbidities [1]. Although the outcomes have improved, the literature still reports 15%–45% morbidity and approximately 5% mortality [2]. The major contributor to unfavorable outcomes of the Whipple procedure is a pancreaticojejunostomy (PJ) leak [3]. The spectrum of postoperative PJ leaks varies from a simple, non-significant biochemical leak to one that worsens postoperative outcomes. Surgeons have devised various techniques, including external PD stenting, internal PD stenting, pancreaticogastrostomy, duct-to-mucosa anastomosis, and dunking, to protect this anastomosis [4-7]. A well-performed surgical technique still carries a risk of leakage as numerous other factors govern the outcomes of these patients.

Initially pioneered by Kurosaki and Hatakeyama [8] in 2004, the omental roll-up technique has been used in a few reports with varied results. The hypothesis behind the use of omentum is its inherent property to bind to the anastomosis at the site of the leak and prevent further catastrophic events [3]. This study was intended to demonstrate the efficacy of the omental roll-up technique in PD for preventing pancreatic fistulas.

This was a prospective, randomized control study carried out in the Department of General Surgery, PGIMER, Chandigarh, India. Fifty-eight patients who underwent PD in the department between January 2020 and July 2023 were enrolled in the study. Participants who provided consent for surgery were included. Patients who did not provide consent and those with metastatic disease were excluded. This study was approved by the Institutional Ethics Committee (letter no. INT/IEC/2020/00448 dated 16/05/2020) and was registered in the Central Trial Registry under number CTRI/2021/06/033991. The patients who were eligible to participate in the study were randomized into two groups using a table of random numbers. The flow chart of the participants selection is shown in Fig. 1.

Fig 1. A flowchart of the participant selection of the study. OW, ommental wrap.

After enrolling, the demographic details, clinical history, and co-morbidities of all patients were recorded. The patients underwent routine biochemical, hematological, and coagulation testing. The patients underwent contrast-enhanced tomography of the abdomen and chest for staging. All patients were optimized for nutrition, coagulopathies, and cholangitis. Endoscopic retrograde cholangiopancreatography and stenting of the common bile duct (CBD) were done in cases of intractable cholangitis and coagulopathies. Patients who were deemed resectable underwent pre-anesthetic, cardiac, and respiratory evaluations according to set guidelines.

After optimization, all patients underwent standard open PD. The group B patients who were randomized to the PJ without the omental roll-up technique underwent duct-to-mucosa or invagination anastomosis, according to the decision of the operating surgeon. The patients randomized to the omental roll-up technique arm underwent PJ followed by an omental flap, which was made from the greater omentum. The greater omentum was divided longitudinally along the avascular area, preserving one or two omental branches of the gastroepiploic vessels. The omental flap was then pulled through between the posterior surface of the PJ and the portal vein and rolled over to the anterior surface of the PJ. The rolled omentum was anchored by 4-0 Prolene stitches between the omentum and seromuscular layer of the jejunum and pancreatic parenchyma (Fig. 2–4).

Fig 2. Pancreaticojejunostomy being performed.

Fig 3. Omentum division being performed for roll-up.

Fig 4. Completed omental roll-up around the pancreaticojejunostomy site.

Standard postoperative care was given to all the patients. All patients were shifted to high-dependency units where their vital signs were measured, and intravenous fluids were infused as required. A test saline feed test was administered through feeding jejunostomy on postoperative day (POD) 1 followed by gradual increase to other high calorie enteral feeding. The nasogastric tube (NG) was removed when the output decreased to less than 200 mL. Oral feeding was started after NG removal and was gradually increased according to the patient’s tolerance. Drain fluid quality and quantity were constantly measured. Fluid amylase levels were measured on PODs 1 and 3. It was corroborated by serum amylase measurements, and grading of the pancreatic fistula was done according to the International Study Group of Pancreatic Fistula (ISGPF) classifications [9]. The postoperative complications were graded using the Clavien–Dindo classification [10], and PD complications, such as delayed gastric emptying, pancreatic fistula, hemorrhage, collections, and wound infections, were noted and managed. All patients were followed up until 90 days of the surgery.

Statistical analysis

Data were entered into a Microsoft Excel data sheet (Microsoft) and analyzed using SPSS 22 version software (IBM Corp.). Categorical data are presented as frequencies and proportions. The chi-squared test or Fischer’s exact test (for 2 × 2 tables only) was used as a test of significance for qualitative data. Continuous data are presented as the mean and standard deviation. An independent t-test was used as a test of significance to identify the mean difference between two quantitative variables. Microsoft Excel and Microsoft Word were used to obtain graphical representations of the data, such as bar diagrams and pie diagrams. A p-value (probability that the result is true) of < 0.05 was considered statistically significant after assuming all the rules of statistical tests. Statistical software (Microsoft Excel and SPSS version 22) was used to analyze the data.

Demographic data

The mean age of the patients in group A was 57.1 ± 14.3 years, and 51.2 ± 10.7 years in the non-wrap group. Jaundice (77.5%) was the most common clinical presentation, followed by abdominal pain (72.4%). All patients in the study belonged to Eastern Co-operative Oncology group class I except for one patient who was randomized to the omental wrap group. The mean levels of tumor markers, such ascarbohydrate antigen CA19.9 and carcinoembryonic antigen, were comparable in both groups. The distribution of malignancy locations was similar between the groups. The demographic and laboratory parameters are shown in Table 1.

Table 1 . Demographic, clinical, and laboratory parameters of the study population

Parameter	Group A - omental roll-up (n = 29)	Group B - no-omental roll-up (n = 29)	p-value
Age (yr)	57.1 ± 14.3	51.2 ± 10.7	0.45
M:F	17:12	8:21	0.06
Diabetes mellitus	4	1	0.143
Hypertension	7	3	0.361
Active smoker	2	1	0.309
Alcoholic	2	2	0.143
Clinical history
Pain abdomen	22	20	0.69
Jaundice	23	22	0.667
Pruritis	12	18	0.68
Fever	6	8	0.67
Weight loss	17	12	0.273
Anorexia	14	8	0.25
BMI (kg/m2)	21.1 ± 1.8	24.3 ± 5.4	0.03
ECOG 1	28	29	0.30
Preoperative biliary drainage	20	9	0.07
Lab parameters
Haemoglobin (g/dL)	11.5 ± 2.1	12.1 ± 1.9	0.41
Total leucocyte count	8,632.0 ± 3,011.3	8,098.7 ± 2,353.7	0.59
Albumin (g/dL)	3.6 ± 0.5	3.7 ± 0.5	0.51
CA19.9 (IU/dL)	92.4 ± 131.2	265.4 ± 524.0	0.22
CEA (IU/dL)	21.9 ± 55.0	20.4 ± 38.8	0.93
Carcinoma head of pancreas	16	17	0.98
Cholangiocarcinoma	7	5	0.76
Periampulary	6	6	> 0.99
Duodenal	0	1	0.83

Values are presented as mean ± standard deviation or number only.

M, male; F, female; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; CEA, carcinoembryonic antigen.

Intraoperative parameters

The intraoperative findings of the patients randomized to both groups were comparable (Table 2). CBD diameters were similar in group A and group B (12.6 ± 5.3 mm vs. 17.2 ± 10.3 mm, p = 0.13). The pancreatic duct diameter (p = 0.91), PJ type (p > 0.99), and pancreatic consistency (p = 0.4) were also similar between the groups. Blood loss was significantly higher in the patients with no wrap (p = 0.04).

Table 2 . Intraoperative variables

Parameter	Group A - omental roll-up (n = 29)	Group B - no-omental roll-up (n = 29)	p-value
CBD diameter (mm)	12.6 ± 5.3	17.2 ± 10.3	0.13
PD diameter (mm)	4.06 ± 2.01	4.60 ± 2.43	0.91
PJ anastomosis			> 0.99
Dunking	10	10
Duct to mucosa	19	19
Pancreatic consistency			0.4
Firm	20	24
Soft	9	5
Duration of surgery (h)	5.5 ± 0.5	5.5 ± 0.8	0.89
Blood loss (mL)	233.33 ± 9.57	343.33 ± 177.14	0.04

Values are presented as mean ± standard deviation or number only.

CBD, common bile duct; PD, pancreaticoduodenectomy; PJ, pancreaticojejunostomy.

Drain fluid amylase

Mean drain fluid amylase levels on POD 1 and POD 3 were comparable between the groups (Table 3).

Table 3 . Drain fluid amylase levels on days 1 and 3

Parameter	Group A - omental roll-up (n = 29)	Group B - no-omental roll-up (n = 29)	p-value
POD 1 (IU/L)	1,280.0 ± 1,812.6	1,299.7 ± 1,626.9	0.97
POD 3 (IU/L)	372.9 ± 503.6	392.7 ± 649.4	0.92

Values are presented as mean ± standard deviation.

POD, postoperative day.

Postoperative data

The patients were graded using the ISGPF classification. None of the patients developed grade C fistulas. The incidence of grade A (p > 0.99) and grade B fistulas (p = 0.54) was similar in both groups. Delayed gastric emptying was also similar in both groups. Other morbidities after surgery classified according to the Clavien–Dindo classification were also comparable. The findings are shown in Table 4.

Table 4 . Postoperative variables and complications

Parameter	Group A - omental roll-up (n = 29)	Group B - no-omental roll-up (n = 29)	p-value
Pancreatic fistula
Grade A	8	8	> 0.99
Grade B	2	3	0.54
Grade C	0	0
Delayed gastric emptying
Grade A	2	3	0.54
Grade B	10	6	0.40
Grade C	2	2	> 0.99
Wound infections	7	8	0.61
Clavien–Dindo classification
II	24	29	0.06
III A	4	0	0.14
III B	1	0	0.30
Length of postoperative stay (day)	14.9 ± 5.7	14.6 ± 4.9	0.89

Length of stay is presented as mean ± standard deviation. All other values as propotions.

PD has become a common procedure performed in many oncological centers of the world [1]. Although this is a complex procedure with high mortality and morbidity traditionally, advancements in perioperative care have led to acceptable morbidity and mortality. The procedure is now being performed in older age groups with favorable outcomes. The majority of PD complications are attributed to PJ anastomotic compromise [11]. Various surgical and inherent factors are considered responsible for the leak. A non-dilated PD, soft texture of the pancreas, high blood loss, and poor nutritional status of the patient are a few of the factors influencing healing [12].

Various surgical, pharmacological, and nutritional interventions have been tried to prevent a PJ leak [13]. However, the outcomes of the interventions have varied, and these techniques must be individualized for each patient. The authors of the current study used an omental roll-up technique around the PJ site to seal the leakage site using the inherent property of the omentum. It also might prevent a further cascade of events that occur after a clinically significant leak is established.

The current study was a prospective, randomized, controlled trial, which was designed to establish the superiority of the omental roll-up technique over standard PJ methods. The patient population in this study was in their sixth decade of life, with a slightly higher number of females than males. Jaundice was the most common symptom, followed by abdominal pain. The body mass index (BMI) was significantly higher in the non-roll-up group compared to the other group. These findings are in concordance with other studies published in this region of the world [14].

The intraoperative findings of the study population in both groups were comparable. The consistency of the pancreas, duct diameter, and the type of anastomosis were similar. A significant increase in blood loss in the non-omental roll-up group was seen. This may be attributed to the higher BMI in this group of patients. However, the total duration of surgery was similar, indicating that the omental roll-up technique does not take much time to perform. This adds to the armamentarium of surgeons to prevent a clinically significant postoperative pancreatic fistula (POPF).

Drain fluid amylase levels were similar on PODs 1 and 3 in both groups, indicating the non-superiority of the omental roll-up over standard PJ anastomosis. The POPF rate in the study was 3.44% in the omental roll-up group and 3.79% in the control arm. The rates were lower than in previous studies where the omental roll-up technique was used. Previous studies reported a POPF rate from 8% to 20% in patients where the omental roll-up technique was used [2,3]. Grade III A and B morbidity were higher in the omental roll-up technique group compared to the controls, and the increased morbidity in the group might have led to a slight increase in the length of stay of these patients. This variable was comparable but did not reach statistical significance. Other authors have advocated for the use of omental flaps to protect blood vessel stumps from bleeding [15].

Although the omental roll-up technique did not emerge as superior to the standard PJ technique, using the omentum has been advocated in other areas, like esophageal anastomosis and rectal anastomosis [16,17]. The omentum’s inherent property of forming a vascular adhesion around the PJ anastomosis site might help to prevent anastomotic leaks, and in case of a leak, it can localize the leak in some patients, thereby improving outcomes after PD. This study further strengthens the results of a systematic review by Ramia et al. [18], in which they could not establish the superiority of the omental roll-up technique over the standard PJ technique.

The major limitation of the study is the low sample size. This may be improved by recruiting a large number of patients, as this may allow for a further subgroup analysis between high-risk and low-risk patients. Further, a multicenter study may be planned to study the effectiveness of the omental roll-up technique in pancreatic surgeries.

To conclude, the omental roll-up technique can be a useful procedure in the armamentarium of pancreatic surgeons. This technique can be performed easily without increasing the operative time. However, its superiority over standard PJ without an omental roll-up still needs to be established.

None.

No potential conflict of interest relevant to this article was reported.

Conceptualization: SJ, CT, YRS, KCK, LK. Data curation: All authors. Methodology: SJ, LK, CT. Writing - original draft: AG, LK. Writing - review & editing: LK.