| Abstract|| |
Background and objectives: Acute pancreatitis is a serious complication of ERCP. Octreotide as prophylaxis against ERCP-induced hyperamylasemia has produced conflicting results. A review article has called for additional controlled studies. This work was undertaken to see the effect of octreotide in ERCP-induced enzyme changes in a predominantly Saudi population. Subjects & methods: The setting was a university teaching hospital, Eastern Saudi Arabia. The study was prospective, randomized and controlled and the subjects were 50 consecutive adult in-patients. Octreotide, 200 tg subcutaneous, was used in the study group (27 patients). Levels of serum amylase and lipase were estimated three times post-ERCP; mean values were compared with the control group (23 patients) using student t test. Results: A total of 50 patients were studied. Their mean age was 43 (range 19 to 70); 30 were female, a male:female ratio of 1:1.5. The two groups were comparable in terms of age, sex and nationality as well as clinical, haematological and biochemical variables. In both groups, the serum levels of amylase and lipase 4 hours post-ERCP were significantly higher compared with base line levels. However, there were no statistical differences between the mean post-ERCP values within as well as between the two groups of patient studied. However, the pattern of response appeared to be different when amylase was compared with lipase. Conclusion: Prophylactic octreotide, in the regimen used in this study, does not protect against post-ERCP hyperamylasemia and hyperlipasemia. The observed apparent difference in the pattern of serum amylase and lipase remains to be confirmed.
Keywords: ERCP, Octreotide, Pancreatitis.
|How to cite this article:|
Al Awad N. Effect of octreotide on the prevention of hyperamylasemia after ERCP in Saudi Arabia: A prospective study. Saudi J Gastroenterol 2000;6:37-40
|How to cite this URL:|
Al Awad N. Effect of octreotide on the prevention of hyperamylasemia after ERCP in Saudi Arabia: A prospective study. Saudi J Gastroenterol [serial online] 2000 [cited 2022 Dec 7];6:37-40. Available from: https://www.saudijgastro.com/text.asp?2000/6/1/37/33503
In 1987, Tamimi et al reported an increased frequency of cholecystectomy in Eastern Saudi Arabia. Al Mulhim et al confirrued the trend in a follow-up study, especially with the advent of laparoscopic surgery, and, Al Awad et al have documented the frequency of gallstone pancreatitis in the same region. The inference must be that the number of endoscopic retrograde cholangio pancreatography (ERCP) being performed also has increased. If this is so, then the potential for increased ERCP-associated morbidity and therefore its prevention, must be of general concern.
Acute pancreatitis is one of the serious complications of ERCP, with a reported incidence of 1%-6% . A more common adverse event is that the pancreas reacts to ERCP by raised levels of serum amylase and lipase. The incidence of post-ERCP hyperamylasemia ranges from 40-50%, to as high as 70%.
Octreotide, a somastostatin analogue, has been used in an attempt to prevent these complications, but the results are conflicting. Whereas three authors found octreotide beneficial,,, three others said it had no effect ,, and one found that it worsened the hyperamylasemia [Table - 1].
The controversy is highlighted in review articles. For examples, Jerkins and Berein stated: "In preventing the complications following ERCP, octreotide has no beneficial effect and may be deleterious". In another review, Maton had lamented "the paucity of adequate controlled studies to estimate the potential usefulness of octreotide". As far as the author is aware, there are no previous reports from Saudi Arabia on the subject. This paper seeks to address this issue.
| Patients and methods|| |
The study was conducted in the departinent of Surgery and the Endoscopy Unit, King Fahd Hospital of the University, Eastern Saudi Arabia. It was prospective and randomized. All adult inpatients scheduled for ERCP were eligible for enrolment. Total of 50 patients were included (27 patients treated and 23 served as a control group).
In addition to patients' dermographic data, the following were recorded on admission: current abdominal pain and tenderness, vomiting and jaundice; history of jaundice, pancreatitis and alcohol consumption. Investigations were complete blood count; liver function tests; serum amylase, lipase and calcium; and fasting blood sugar. Liver, gall bladder, bile ducts and pancreas were evaluated by ultrasonogram. ERCP findings were documented.
Randomization was achieved by opening a presealed envelope. Octreotide, 200 gg (1.0 ml), was administered by subcutaneous injection oncall to endoscopy, and, at 8 and 16 hours post-ERCP.
Correspondingly, the control group received 1.0 ml of normal saline.
After an overnight fast, all patients were sedated with 10 mg i.v. diazepam. All ERCPs were performed by the same highly experienced endoscopist using Olympus 11 mm. At the end of the procedure, patients were returned to the ward and closely monitored. Post-ERCP, blood samples were taken 4, 8 and 24 hours for levels of amylase and lipase.
Student t test was the statistical tool used to compare the means of continuous variables.
| Results|| |
The study was closed with completion of the first 50 consecutive patients. There were 41 Saudis and nine non-Saudis; 30 were females, a male:female ratio of 1:15. Their mean age (SD) was 43 (16) years (range 19-70; [Figure 1]). The two groups were comparable in terms of clinical, haematological and biochemical variables [Table - 2] and [Table - 3]. Papillotomy was not indicated in 43 patients; it was successful in six of the remaining seven in whom it was performed.
Base line levels of serum amylase showed three clear outliers -- 772, 3, 780 and 3.974 I.U./L. These were therefore excluded from further analysis. [Table - 4] summarizes the findings of serum amylase and lipase.
Two cases of acute pancreatitis occurred in the series. The first was one of the three outliers who had base line hyperamylasemia. The other was in the octreotide group. However, because the numbers involved are small, no valid inferences can be drawn from this observation. Both cases of pancreatitis were mild and resolved without any complications.
In both groups, all the three readings of the serum amylase and lipase post-ERCP were significantly higher compared with base line levels. The levels gradually returned towards normal within 24 hours. However, within each group, amylase increase peaked by over 2-fold as contrasted with lipase increase of over 4-fold. This effect was consistent for readings at 4 and 8 hours; but, it was lost at the 24 hour reading [Table - 4].
Between groups, the findings were suggestive but not statistically significant, that the mean post-ERCP values were consistently lower for the octreotide group. Thus, for amylase, the 4-hour rises were about 2-fold for octreotide but nearly 3-fold for placebo group. For lipase, the corresponding peak increases, also at 4 hours, were 4-fold and 5-fold [Table - 4].
| Discussion|| |
The study compares favourably with others from the literature. First, it was prospective, randomized and controlled. Secondly, in five out of the seven reports found by Medline search, the numbers of subjects were less than 100, being 60, 60, 63, 73 and 84 [Table - 1]. Thirdly, regarding the timing of postERCP octreotide, different authors employed different regimens [Table - 1]. However, pre-ERCP octreotide is the important issue. This is because the intention is to prevent any hyperamylasemia which may be induced by ERCP.
In this study, the control and octreotide groups were comparable in terms of the distribution of age, sex and natiobnality, as well as the clinical, haematological and biochemical varibles specified [Table - 2] & [Table - 3].
For the study population as a whole, the ERCPinduced hyperamylasemia and hyperlipasemia occurred as expected, and declined within 24 hours. Within each group, differences in the pattern of increase were observed when amylase was compared with lipase.
Between groups, there were no statistically significant differences between the mean post-ERCP values of serum amylase and lipase, although the results were suggestive of lower levels in the octretide group. This finding applied also to the subgroup of six patients who had successful papillotomy.
It was concluded that, these results would tend to support the three others cited from the literature that prophylactic octreotide, in the regimen used in this study, failed to protect against ERCP-induced hyperamylasemia and hyperlipasemia. The apparent difference observed in the pattern of serum amylase and lipase remains to be confirmed, but, it had no demonstrable clinical significance.
| Acknowledgment|| |
I would like to express my appreciation to Professor Abdulaziz A. Al Quorain, Endoscopy Unit, Division of Gastroenterology, Internal Medicine Department, for performing the ERCP on all the patients.
| References|| |
|1.||Tamimi TM, Wosornu L, Al Khozaim AA, Abdul Ghani A. An epidemiology of gallstones: A decade of 2,854 cholecystectomies in the Eastern Province. Lancet 1990;336:12355-7. |
|2.||Al Mulhim AA, AI Quorain AA, Wosomu L. Increased rates of cholecystectomy following the introduction of laparoscopic cholecystectomy in Saudi Arabia. World J Surg 1998(Accepted). |
|3.||Al Awad N, AI Quorain AA, Al Mulhim K, Al Mulhim AM, Al Awami MS, Wosomu L. Acute pancreatitis in Eastern Saudi Arabia: A clinical study and comparison with other Gulf States. Kuwait Med J 1998(In press). |
|4.||Testoni PA, Lella F, Bagnolo F, Buizza M, Colombo E. Controlled trial of octreotide in the prevention of hyperamylasemia induced by endoscopic papillosphincterotomy. Italian J Gastroenterol 1994;26:431-6. |
|5.||Arcidiacono R, Gambitta P, Rossi A, Grosso C, Bini M, Zanasi G. The use of long-acting somatostatin analogue (octreotide) for prophylaxis of acute pancreatitis after endoscopic sphincterotomy. Endoscopy 1994;26:715-8. |
|6.||Arvanitidis D, HatzipanayiotisJ, Koutsounopoulos G, Frangou E. The effect of octreotide on the prevention of acute pancreatitis and hyperamylasemia after diagnostic and therapeutic ERCP. Hepatogastroenterol 1998;45:248-52. |
|7.||Tulassay A, Papp J. The effect of long-acting somatostatin anologue on enzyme changes after endoscopic pancreatography. Gastrointest Endosc 1991;37:48-50. |
|8.||Binmoeller KF, Harris AG, Dumas R, Grimaldi C, Deimont JP. Does the somastotatin analogue octreotide protect against ERCP-induced pancreatitis? Gut 1992;33:1129-33. |
|9.||Sternlieb JM, Aronchick CA. Retig JN, Dabezies M, Saunders F, et al. A multicenter, randomized, controlled trial to evaluate the effect of prophylactic octreotide on ERCPinduced pancreatitis. Am J Gastroenterol 1992;87:1561-6. |
|10.||Testoni PA, Lella F, Bagnolo F, Caporuscio S, Cattani L, Colombo E, Buizza M. Long-term prophylactic administration of octreotide reduces the rise in serum amylase after endoscopic procedures on Vater's papilla. Pancreas 1996;13:61-5. |
|11.||Jenkins SA, Berein A. The relative effectiveness of somatostatin and octreotide therapy in pancreatic disease. Alimentary pharmacology & Therapeutics 1995;9:349-61. |
|12.||Maton PN. Expanding uses of octreotide. Baillieres Clin Gastroenterol 1994;8:321-7. |
Naif Al Awad
Assistant Professor in Surgery, King Fahd Hospital of the University, P.O. Box 40060, Al Khobar 31952
Source of Support: None, Conflict of Interest: None
[Table - 1], [Table - 2], [Table - 3], [Table - 4]